HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR
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Model Number SAM350P |
Device Problems
Defective Component (2292); 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 06/29/2021 |
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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Inability to use the device shock button, may prevent or delay defibrillation which could result in adverse consequences.No patient involvement.
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Manufacturer Narrative
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Heartsine evaluated the customer's device and verified the event was logged in the device's memory; however, the reported issue could not be duplicated in testing, and the investigation was inconclusive as no fault was found on the returned device.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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The distributor contacted heartsine to report that their device was showing the "shock key stuck" error message.Inability to use the device shock button, may prevent or delay defibrillation which could result in adverse consequences.There was no patient involvement reported with this event.
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Search Alerts/Recalls
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