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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2022
Event Type  malfunction  
Event Description
During investigation of the monitor for an unrelated issue, a reportable malfunction was found.The monitor was unable to complete essential performance testing.
 
Manufacturer Narrative
During investigation for an unrelated event, a reportable malfunction was found.The monitor was unable to power on.The cause for failure was isolated to a defective u104 pxa component.The root cause for the defective u104 pxa processor could not be positively identified.No adverse event 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 Key16511898
MDR Text Key311110173
Report Number3008642652-2023-02221
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 03/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2023
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 Received03/09/2023
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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