Model Number 350P |
Device Problem
Key or Button Unresponsive/not Working (4063)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
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Event Description
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A distributor contacted heartsine to report that a customer¿s device was not responding to on/off button presses.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
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Manufacturer Narrative
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Heartsine has made multiple attempts to contact the customer regarding the status of their device, but no response has been received from the customer.The device was not returned to heartsine for investigation.No additional information will be forthcoming at this time.The cause of the reported issue could not be determined.If the device is returned to the manufacturer the investigation will be reopened.
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Event Description
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A distributor contacted heartsine to report that a customer¿s device was not responding to on/off button presses.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
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Event Description
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A distributor contacted heartsine to report that a customer¿s device was not responding to on/off button presses.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.
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Manufacturer Narrative
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Heartsine's investigation of the device confirmed the reported fault as upon receipt the device was found to be powering on automatically.This fault was attributed to corrosion on the membrane tail.The corrosion on the membrane tail would suggest that the device had been stored outside the indicated conditions.This was further confirmed by corrosion on the screws.The device was scrapped by heartsine and the customer was provided with a replacement device.
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Search Alerts/Recalls
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