Model Number LIFEVEST WCD 4000 SYSTEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Rash (2033); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)
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Event Date 07/23/2022 |
Event Type
Injury
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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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Event Description
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A us distributor contacted zoll to report that a patient developed a weeping heat rash on their back from the lifevest equipment.There was no alleged device malfunction contributing to the irritation.The patient reported going to the er but stated that they could not help.The patient¿s nurse inquired about using a steroid cream for the skin irritation.It is unclear if the nurse applied the cream to the skin irritation.Reporting out of abundance of caution.Outcome of the irritation is unknown as follow up attempts were unsuccessful.
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Search Alerts/Recalls
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