HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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Model Number 350P |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2023 |
Event Type
malfunction
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Event Description
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The customer contacted heartsine to report that their device unexpectedly powered off.There was no report of patient use associated with the reported 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 evaluated the customer's device and was unable to duplicate the reported issue; however, heartsine observed a separate issue with the device emitting barely audible voice prompts from the speaker.Heartsine determined that the cause of the observed issue was due to debris infiltrating the device while it was stored outside of the indicated conditions.The device was scrapped by heartsine and the customer received a replacement device.
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Event Description
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The customer contacted heartsine to report that their device unexpectedly powered off.There was no report of patient use associated with the reported event.
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Search Alerts/Recalls
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