Model Number 20 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A third-party service agent performed an initial evaluation on the customer's device and observed that the device logged an event code which is indicative of a device failure which could result in a partial loss of defibrillator output energy.However, no defibrillation energy output issues were observed during evaluation.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 that their device gave a 'failed shock' message after testing the device.Upon inspection, by the third-party service agent, it was observed that the device had logged an event code in its memory that is indicative of a device failure which could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no patient use associated with the reported event.
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Manufacturer Narrative
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The third-party service agent further evaluated the customer's device and verified and duplicated the reported issue.It was determined the cause of the issue was the therapy pcba.The customer chose to trade the unit in for a new device rather than repair.The original device was scrapped by physio-control, and further root cause was not determined.
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Event Description
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The customer contacted physio-control to report that their device gave a 'failed shock' message after testing the device.Upon inspection, by the third-party service agent, it was observed that the device had logged an event code in its memory that is indicative of a device failure which could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no patient use associated with the reported event.
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Search Alerts/Recalls
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