Model Number 866199 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
Event Type
malfunction
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Event Description
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It was reported to philips that the efficia dfm100 exhibited an abnormal ecg waveform.There was no reported patient impact or injury.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.
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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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Manufacturer Narrative
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This report is based on information provided by philips authorized service provider (asp) and has been investigated by the philips complaint handling team.Philips received a complaint on the dfm100 device indicating that the ecg waveform is abnormal.The asp evaluated the device on site.It was determined that this was a malfunction of the therapy cable, which was replaced, and the device was returned to full functionality.The device remains at the customer site and no further evaluation is warranted at this time.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the therapy cable.The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The asp replaced the therapy cable to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.
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Search Alerts/Recalls
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