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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 Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 12/13/2022
Event Type  malfunction  
Manufacturer Narrative
Device evaluation of monitor has been completed.The reported problem (resets) has been confirmed.Upon investigation the monitor reset during a pulse test.The cause for the failure was isolated to defective t2 transformer on the defibrillator pca and defective q2 on ca board.The root cause for the defective transformer could not be positively identified.There were no adverse events associated with the monitor malfunction.
 
Event Description
A us distributor reported that a monitor resets during pulse delivery.
 
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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 Key16129700
MDR Text Key307028344
Report Number3008642652-2023-00284
Device Sequence Number1
Product Code MVK
Combination Product (y/n)N
Reporter Country CodeUS
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 01/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2023
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 Received01/03/2023
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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