HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATORS
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Model Number 350P |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2022 |
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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The customer contacted stryker to report that their device failed to power on.In this state, the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported during the event.
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Manufacturer Narrative
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Heartsine's investigation of the device confirmed the reported fault.Upon receipt, the device was powered on, and the green status led flashed alongside a constantly activated failure chirp, which would account for the reported 'high-pitched noise.' furthermore, the device failed to power off via the on/off button.These faults were attributed to corrosion on multiple tracks of the membrane tail.The corrosion on the usb contact collars, membrane tail, and within the membrane panel would indicate the device had been stored outside the indicated conditions.Heartsine scrapped the device, and the customer received a replacement device.
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Event Description
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The customer contacted stryker to report that their device failed to power on.In this state, the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported during the event.
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Search Alerts/Recalls
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