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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 WCD 4000
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 09/09/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation of monitor sn (b)(4) has been completed.The reported problem (won't power on) has been confirmed.Upon investigation the monitor was unable to power on.The cause for the failure was isolated to the defibrillator pca and computer/analog board.High voltage travelled to low voltage circuitry, damaging multiple components on the pcas.The root cause for the high voltage travelling to low voltage circuitry could not be positively identified.No adverse event resulted from the monitor malfunction.
 
Event or Problem Description
A us distributor reported that a monitor was not powering on.
 
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Brand Name
LIFEVEST WCD 4000 SYSTEM
Common Device Name
WEARABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA 15238 3495
MDR Report Key10729352
Report Number3008642652-2020-09203
Device Sequence Number11494482
Product Code MVK
UDI-Device Identifier00855778005005
UDI-Public00855778005005
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P010030
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model NumberWCD 4000
Device Catalogue Number10A0988
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/12/2020
Initial Report FDA Received Date10/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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