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 07/27/2022 |
Event Type
malfunction
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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 patient involvement reported with the event.
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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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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 unable to be powered off via the on/off button.This fault was attributed to corrosion on the membrane tail.The corrosion observed on the membrane tail, alongside the corrosion on the usb contact collars would indicate the device had been subject to storage outside of the indicated conditions.The device was scrapped by heartsine and the customer was provided with a replacement device.
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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 patient involvement reported with the event.
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Search Alerts/Recalls
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