| Developers: | Philips Healthcare |
| Branches: | Pharmaceutics, medicine, health care |
Content |
2019
Withdrawal of the rejected HeartStart XL+ because of which patients die
At the end of October, 2019 after the death of two patients of Philips recalled the rejected HeartStart XL+ monitors defibrillators which can delay the beginning of therapy and threaten life of patients.
The first response concerned a problem of start of the device: it was reported that the HeartStart XL monitor defibrillator + can not turn on when clicking the button or unexpectedly it tries to be restarted in the middle of work. This defect revealed on the basis of 588 complaints of clients mentions only the devices sold outside the USA and Canada. Because of problems with restart of the monitor defibrillator two patients died.
In certain cases the problem was connected with defect of the software for HeartStart memory management. In other cases fault of the module System On (SOM) installed on the processor printed assembly was the reason. Philips promised to execute updating of the system software and to replace the printed circuit board of the processor which contains the faulty module SOM.
The second response concerned the monitors defibrillators of the same model released till 2017. It is supposed that the rotary selector switch of therapy can not work on these devices. The similar defect can lead to the fact that the device will not be started, will not be able to activate the selected function or will direct current of too high intensity to the patient. According to Philips, messages about the undesirable phenomena which developed with respect thereto defect did not arrive yet. It is supposed that if the HeartStart XL+ monitor defibrillator released till 2017 does not bring problems to the user, it can remain in operation.
All HeartStart XL devices + with model number 861290 were laid off in December, 2017.[1]
Withdrawal of the rejected defibrillators after the death of the patient
At the beginning of July, 2019 Philips Healthcare recalled from the market the rejected monitors defibrillators after the death of the patient. The company warned clients that the power module of alternating current in the external HeartStart MRx monitor defibrillator can easily fail and threatens with a lethal outcome.
 | "The revealed failures are caused by failure of internal components, use of excessive solder by production, physical damages to the operation course on places, or the expiration of service of power module of alternating current", - representatives of the company reported Zdrav.Expert. |  |
The Philips company reports that the power module of alternating current of M3539A for a monitor/defibrillator of HeartStart MRx can quicker fail fixed term of service.
If these failures or interruptions in power supply occur in the absence of the charged accumulator in the HeartStart MRx device, it can lead to interruption of operation of control devices or a delay in carrying out shock or cardiotherapies that is extremely dangerous to the patients needing resuscitation actions. The faulty power module of alternating current will not be able to charge the battery that will lead to shutdown of the device if the user does not react to alarms and warnings of the low level of battery power. Therefore the company urges to install always in the device the charged battery as it is specified in the operating instruction, irrespective of existence or lack of power supply from the alternating current main in the place of operation.
Since September, 2004 Philips receives about 100 complaints a year concerning this problem. Presumably, owing to failure of power module of alternating current one patient already died.
Due to the potential problems, the Philips company released Warning of security. In this document Philips reminded users of the actions necessary for risk reduction for patients. Also Philips kindly asks users to follow the instruction and to monitor device battery power level. Philips makes replacement of faulty power modules of alternating current of M3539A.
Regulatory bodies of the USA already estimate the strategy of the producer. As the representative of the company reported, after risk assessment for patients and complete examination of a problem regulatory bodies will publish necessary information on the Internet.
The current warning concerns the HeartStart MRx monitors defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8 and M3536M9.[2]
2018: A withdrawal of the rejected batteries
At the beginning of December, 2018 Philips Healthcare withdrew from the market of the battery for automatic outside defibrillators of HeartStart MRx.
The lithium-ion Philips M3538A accumulators manufactured during the period from December 28, 2017 to March 20, 2018 and intended for HeartStart MRx monitor/defibrillator can have fault of an internal component that does not allow them to be loaded or to provide a power supply of a defibrillator, according to the statement of regulatory bodies of Great Britain. Thus fault belongs to the top class of risk, threat of life and health of the patient. FDA did not issue own statement yet.
Delivery of batteries for HeartStart MRx devices was suspended because of the revealed production problems, the consultant explained. Possibly, the considerable delay in accomplishment of the previous orders will be observed, but it is a compulsory measure. Regulatory bodies of Great Britain reported that they warned the company: in the recommendations of January 15, 2018 provided to Philips Healthcare it was told about deficit of operational batteries, but Philips expected resuming of deliveries till January 23, 2018.
Philips stated that it notified regulating authorities in the countries where extended faulty batteries. The company provided the notification on security to inform clients on a problem and conditions of possible development of complications. Philips recommends to clients to replace immediately faulty batteries and to utilize. 1880 copies of faulty batteries were around the world sold.
The company stated that it did not receive messages about harming the patient or the user in connection with this potential problem. Representatives of the company assured that clients will contact Philips if their device does not work properly.[3]
Notes
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