Model Number 861290 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
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Event Description
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It was reported the xl+ device showed a red "x" signal.No patient involvement reported at this time.
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Event Description
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This report is based on information provided by philips field service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart xl+ defibrillator/monitor indicating show red "x" signal.The device was not in clinical use at the time the issue was discovered.There was no reported patient impact/injury.The fse (field service engineer) onsite checked and confirmed the customer execute the wrong method of operation check.Fse redo the operation check, test all function ok.Device returned to full functionality.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
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Manufacturer Narrative
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Updated summary and code grids.
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Search Alerts/Recalls
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