Model Number 8900-0214-01 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Abrasion (1689); Contusion (1787)
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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.Please refer to the attached user medwatch report that zoll medical has received.
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Event Description
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Complainant alleged that while defibrillating a patient (age & gender unknown) during cardioversion, after removing the electrode pads, tears/abrasions were found on the patient skin.Complainant indicated serious injury of tears/abrasions found on patient's skin.
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Manufacturer Narrative
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The actual electrode used during the event were not returned to zoll medical coproration for evaluation.No lot number of the electrodes were provided to be able to perform retain sample testing.Additional contact with the customer for the product or information were unsuccessful.The patient's injuries were non-life threatening.Our electrode safety instruction labeling addresses the importance of good placement on the patient.Poor adherence and/or air under the electrode can lead to the possibility of arcing and skin burns.Good skin preparation does not guarantee a burn will not occur and burns from defibrillation is an expected risk.No trend is associated with reports of this type.
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Search Alerts/Recalls
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