Lifepak 15 (defibrillator)

2019

the Withdrawal of 29,952 devices which do not work in emergency situation

At the end of December, 2019 the Stryker company began to recall voluntarily the Lifepak 15 monitors defibrillators with the rejected keyboard which does not work when using in emergency situation.

The company notified clients on a problem, potentially life-threatening patient. It became clear that Lifepak 15 devices not always make blow of a defibrillation after clicking of the Shock button. At the same time on the screen the message "DISCHARGE" is displayed. The problem was connected with gradual oxidation of contacts in the button. Stryker already contacted clients who purchased the rejected devices, and offered them free repair or replacement of the device.

Stryker began to recall voluntarily the Lifepak 15 monitors defibrillators with the rejected keyboard which does not work when using in emergency situation

The company claims that by the end of 2019 the majority of deviations, Lifepak 15 connected with a defibrillator, were detected prior to use. Stryker received two reports on the undesirable phenomena when the Shock button did not work, however patients did not suffer. It is possible to reveal a problem at normal testing of the device.

According to Stryker company, clients can continue to use the Lifepak 15 monitor defibrillator according to the operating instruction, however should execute daily check according to the check sheet of the operator. In particular, it is necessary to execute surely the QUIK-COMBO test — if the defibrillator does not pass it, then on the screen the office message prohibiting to use the faulty device is highlighted. It is supposed that the problem mentions only the keyboard of the device and does not influence other functions. At emergence of any problems clients are recommended to contact the local representative of Stryker.

In general under a response 29,952 defibrillators of Lifepak 15 which numbers begin with V15-2 got. With numbers V15-5 or V15-7 this response does not extend to Lifepak 15 devices.^[1]

Withdrawal of defibrillators after death not less than 6 people

At the beginning of February, 2019 Stryker Corporation began to recall with the market the Lifepak 15 monitors defibrillators in connection with the arisen problems. The company received six messages about lethal cases owing to failure of the device which could not provide the emergency defibrillation.

The producer pays attention that Lifepak 15 can cease to work after makes the first blow of a defibrillation. At the same time the monitor of the device remains empty though LED indicators burn, showing that the defibrillator is included. In such situation Lifepak 15 poses a potential threat of life of the patient as can delay performing therapy and lead to a serious travmatization or death.

Lifepak monitor defibrillator

The company stated that since the beginning of sales of Lifepak 15 it worldwide in 2009 received 58 complaints on this matter, including six messages about deaths in connection with fault of the device. In total the problem can concern 13,003 devices, says the producer.

Stryker addressed clients with potentially defective devices and suggested to provide shortly updated software for an internal component which liquidates fault. The company stated that it hopes to complete maintenance of all mentioned devices by the end of 2019 and asked clients to contact immediately the producer at emergence of this problem.

However in the whole Stryker suggested to continue use of devices in usually mode until updated software solves a problem, and added that automatic self-diagnostics will not define fault as it arises only during a defibrillation. At emergence of blocking in usage time clients are offered to execute immediately reset, according to recommendations of the general section about troubleshooting of the operating instruction.^[2]

Notes