Model Number LIFEVEST WCD 4000 SYSTEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)
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Event Date 06/04/2022 |
Event Type
Injury
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Event Description
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A us distributor contacted zoll to report that a patient had a previous surgery incision and the lifevest irritated the area.Patient reported presence of blood and pus.There was no alleged device malfunction contributing to the irritation.The patient was prescribed an antibiotic and betadine for the skin irritation.The patient¿s nurse instructed patient to place gauze over the irritation.Follow up indicated that the skin irritation improved.
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Manufacturer Narrative
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Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces of the lifevest device as well as the blue(tm) defibrillation gel.
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Search Alerts/Recalls
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