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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 Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/27/2015
Event Type  malfunction  
Manufacturer Narrative
Device evaluation of monitor sn (b)(4) has been completed.The reported problem (code 107 - multiple abnormal shutdowns) has been confirmed.As received, the software flags confirmed that the device had been resetting.Upon evaluation, there was corrosion on components j101, j502, and u613, and the sd card.The corrosion caused the monitor resets.The root cause of the corrosion was ingress of an unknown contaminant.No adverse event resulted from the defective monitor.
 
Event Description
A us distributor returned monitor sn (b)(4) and reported that the monitor had multiple abnormal shutdowns.
 
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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
allison petzold
121 gamma drive
pittsburgh, PA 15238-3495
4129683333
MDR Report Key5101652
MDR Text Key26838591
Report Number3008642652-2015-05849
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
Remedial Action Repair
Report Date 09/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2015
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 Manufacturer08/27/2015
Date Manufacturer Received09/03/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/06/2014
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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