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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
Device Problem Cut In Material (2454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2015
Event Type  malfunction  
Manufacturer Narrative
Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (exposed wires) has been confirmed.Upon investigation the cable connecting the distribution node (dn) to the rear therapy electrodes was pulled from the strain relief.The cause of the messages was the strained cable.The root cause for the strained cable was physical abuse.No adverse event resulted from the defective electrode belt.
 
Event Description
A us distributor returned an electrode belt and reported that an electrode belt had exposed wires.
 
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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 3495
Manufacturer (Section G)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA 15238 3495
Manufacturer Contact
hana casalnova
121 gamma drive
pittsburgh, PA 15238-3495
4129683333
MDR Report Key5394095
MDR Text Key37097160
Report Number3008642652-2016-00442
Device Sequence Number1
Product Code MVK
Combination Product (y/n)N
Reporter Country CodeUS
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 01/21/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2015
Initial Date Manufacturer Received 01/05/2016
Initial Date FDA Received01/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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