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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 01/27/2023
Event Type  malfunction  
Event Description
A us distributor returned a monitor and reported monitor was displaying a service code 110.
 
Manufacturer Narrative
Device evaluation of monitor has been completed.The reported problem (service code 110) was isolated to contamination on the pins of pca jumper j1000, causing the over voltage fault.The root cause for the contamination was ingress of an unknown liquid.Lifevest patient instructions for use remind and warn patients not to expose the lifevest electronic components to liquids.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 Key16454898
MDR Text Key310382795
Report Number3008642652-2023-01937
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 02/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2023
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 Received02/28/2023
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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