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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 Communication or Transmission Problem (2896)
Patient Problem Insufficient Information (4580)
Event Date 06/22/2022
Event Type  malfunction  
Manufacturer Narrative
Device evaluation of monitor has been completed.The reported problem (does not communicate with belt) has been confirmed.Upon investigation the monitor was not properly producing a driven ground signal.The cause for the failure was isolated to a defective r781 driven ground resistor on the computer/analog board.After replacement ran autotest without any issues.The root cause for the open resistor could not be positively identified.There was no adverse event that resulted from the damaged monitor.
 
Event Description
A (b)(6) distributor reported that a monitor does not communicate with belt.
 
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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 Key15055655
MDR Text Key296183647
Report Number3008642652-2022-21145
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 07/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2022
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 Received06/22/2022
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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