Model Number M3716A |
Device Problem
Defibrillation/Stimulation Problem (1573)
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Patient Problem
Skin Tears (2516)
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Event Date 11/21/2022 |
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 that defibrillation electrodes were pasted during the operation, the function was normal during the operation, and the patient's skin and epidermis were found broken at the pasting site after the operation.Additional details have been requested.
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Manufacturer Narrative
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A request was made for the pads to be retuned for investigation, but they have been disposed of by the customer and are not available, so failure analysis is not possible.Based on the information available, there is insufficient information to confirm the reported problem.The patient was treated for the alleged wound and released from the hospital per the information provided by the philips field service engineer.The investigation concludes that no further action is required at this time.H3 other text: the pads were disposed of by the customer.
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Event Description
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It was reported that defibrillation pads were pasted during the operation, the function was normal during the operation, and the patient's skin and epidermis were found broken at the pasting site after the operation.Additional details provided indicated the patient sustained empryosis (skin eruption of pustules) consistent with second degree burns and resulting blisters.The patient was successfully defibrillated, and the wound was sterilized and bandaged.The pads were used with a heartstart xl defibrillator.Cutaneous burns are a known, common risk of defibrillator procedures such as cardioversions but typically does not result in a life-threatening serious injury or permanent impairment.As such, this report has been updated from serious injury to product problem.
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Search Alerts/Recalls
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