Model Number M4735A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Burn, Thermal (2530)
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Event Type
malfunction
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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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The customer reported that a patient experienced a "burn" during a cardioversion procedure.A description and photographs of the reported burn, energy levels and number of shocks delivered, and whether treatment was required for this patient have been requested, but not yet received.Redness of the skin is an expected observation with the delivery of energy via pads.As we do not have any additional information we are considering this to be a serious injury.
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Event Description
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It was reported to philips that while using the heartstart xl monitor / defibrillator, a patient experienced a "burn" during a cardioversion procedure.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.This complaint has been updated from a serious injury to a non adverse event.
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Manufacturer Narrative
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(b)(4) is being considered a duplicate of (b)(4) as the serial numbers are the same and the event was reported through two different sources.Refer to (b)(4) and mdr 1218950-2018-09608 for details on the investigation and conclusion of this case.This mdr (above) coded identical to mdr 1218950-2018-09608.
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Search Alerts/Recalls
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