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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR
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ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number LIFEVEST WCD 4000 SYSTEM
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 11/23/2022
Event Type  malfunction  
Event Description
A us distributor returned a monitor and reported that the response buttons were non-functional.
 
Manufacturer Narrative
Device evaluation of monitor has been completed.The reported problem (response buttons non-functional) was due to the front response button dome being contaminated.The root cause of the contaminated dome is liquid ingress of an unknown contaminant.Lifevest patient training materials have been updated as a reminder not to expose lifevest electronic components to liquid.There was no adverse event that resulted from the damaged monitor.
 
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Brand Name
LIFEVEST WCD 4000 SYSTEM
Type of Device
WEARABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA 15238
Manufacturer (Section G)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA
Manufacturer Contact
zoll mfg corporation
121 gamma drive
pittsburgh, PA 15238
MDR Report Key16121714
MDR Text Key308110055
Report Number3008642652-2023-00242
Device Sequence Number1
Product Code MVK
Combination Product (y/n)N
PMA/PMN Number
P010030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 01/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberLIFEVEST WCD 4000 SYSTEM
Date Manufacturer Received12/30/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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