Model Number M4735A |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Shock from Patient Lead(s) (3162)
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Event Date 12/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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A follow up report will be submitted upon completion of the investigation.
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Event Description
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It was reported to philips that the heartstart xl monitor / defibrillator unintentionally shocked a patient when no users were touching the device.Philips is considering this event to be a serious injury because the patient was unintentionally shocked (treatment administration error).It is unknown if the patient experienced an adverse event, and the outcome of the event is unknown.
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Event Description
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It was reported to philips that the heartstart xl monitor / defibrillator unintentionally shocked a patient when no users were touching the device.Philips is considering this event to be a serious injury because the patient was unintentionally shocked.The issue occurred while the user was monitoring the patient and no adverse event to patient or user was reported.The customer was unable to provide information regarding if the patient required any treatment.No ecg monitoring strips or case event files were provided to philips for review.A philips product support engineer evaluated the logs which were provided by the customer, however, the logs did not show evidence to explain the allegation.The customer declined evaluation of the device from philips.No conclusion can be drawn.The customer scrapped the device due to lack of replacement parts.No conclusion can be drawn.According to service bulletin sb86100166d, the m4735a heart/start xl portable defibrillator/monitor was discontinued on 31-december -2013.All options associated with this defibrillator were discontinued as of 31-december-2013.The end of support date for the device is 31-december -2018.The customer was aware of the end of life terms.
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Manufacturer Narrative
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Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Search Alerts/Recalls
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