Model Number 8900-0224-01 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Partial thickness (Second Degree) Burn (2694)
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Event Type
Injury
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Manufacturer Narrative
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Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
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Event Description
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Complainant alleged that while attempting to monitor a patient (age & gender unknown), after removing the electrode pads, blistering was found on the patient's skin.Complainant indicated that the patient sustained blistering (considered 2nd and 3rd degree burns).Please reference medwatch report numbers 1218058-2022-00136 and 1218058-2022-00137 for a similar report from the same customer.
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Manufacturer Narrative
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The customer was contacted for return of the suspect product and indicated they were collecting the pads for return.However, the electrode pads have not been returned to zoll for evaluation at this time.Additionally, the customer clarified that these pads were only used for monitoring and no energy was delivered during the event.This claim is related to a suspected skin reaction to the pads.The design of the zoll onestep complete pads uses materials that has passed biocompatibility testing.This claim will be reopened when product has been received.
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Search Alerts/Recalls
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