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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL LIFECOR CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR
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ZOLL LIFECOR CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number WCD 4000
Device Problem Cut In Material (2454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/27/2014
Event Type  malfunction  
Event Description
A (b)(6) male patient called zoll customer support to report that a wire was severed at his electrode belt connector.The patient was issued a replacement electrode belt.
 
Manufacturer Narrative
Device evaluation summary: device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (wire damaged at connector) has been confirmed.Upon investigation the electrode belt failed incoming functionality testing.The trunk cable connector was physically damaged.The front pulse wire in the connector was open.The root cause for the open wire could not be positively identified but was likely excessive fore on the connector.No adverse events resulted from the open wire.The patient received a replacement electrode belt.
 
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Brand Name
LIFEVEST WCD 4000 SYSTEM
Type of Device
WEARABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ZOLL LIFECOR CORPORATION
pittsburgh PA 15238 349
Manufacturer Contact
zachary nelson
121 gamma dr
pittsburgh, PA 15238-3495
4129683333
MDR Report Key3879607
MDR Text Key4461944
Report Number3008642652-2014-01633
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 Other
Remedial Action Replace
Type of Report Initial
Report Date 05/27/2014
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
Device Operator Lay User/Patient
Device Model NumberWCD 4000
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/30/2014
Initial Date Manufacturer Received 05/03/2014
Initial Date FDA Received05/30/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age49 YR
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