Model Number 15 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
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Event Description
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The customer contacted physio-control to report their device did not pass the self-test.Upon evaluation of the customer's device, physio-control observed that an event code is logged in the memory of their device.The event code is indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform, resulting in a monophasic shock.There was no patient involvement reported with the event.
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Manufacturer Narrative
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Stryker evaluated the customer's device and the reported issue was able to be verified and able to be duplicated.During evaluation two event codes were found logged in the device's memory.One event code is indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform, resulting in a monophasic shock.The other event code logged is related to a potential failure of the device to deliver defibrillation energy.It was determined that the cause of the failure was the therapy pcba.The therapy pcba was replaced to resolve the issue.The device passed functional and performance tests and was returned to the customer.B5 has been updated: additionally, the defibrillator output energy may be reduced by up to approximately 20% from the selected energy level.As a result, the wrong defibrillation therapy would be delivered, if it were necessary.
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Event Description
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The customer contacted physio-control to report their device did not pass the self-test.Upon evaluation of the customer's device, physio-control observed that an event code is logged in the memory of their device.The event code is indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform, resulting in a monophasic shock.There was no patient involvement reported with the event.Updated: additionally, the defibrillator output energy may be reduced by up to approximately 20% from the selected energy level.As a result, the wrong defibrillation therapy would be delivered, if it were necessary.
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Search Alerts/Recalls
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