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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 03/11/2014
Event Type  malfunction  
Event Description
A review of service data detected a reportable problem.Upon investigation, the trunk cable connector on electrode belt sn (b)(4) was severed.The last pt to use this electrode belt did not report any deficiencies.
 
Manufacturer Narrative
Device evaluation summary: device evaluation of electrode belt sn (b)(4) has been completed.Upon investigation the trunk cable connector was severed from the trunk cable.The root cause for the damage could not be positively identified but was likely physical abuse.No adverse event resulted from the defective electrode belt.The last pt to use this electrode belt did not report any deficiencies.
 
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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 Key3795535
MDR Text Key4382893
Report Number3008642652-2014-01080
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 Other,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/04/2014
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 Manufacturer03/10/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/11/2014
Initial Date FDA Received04/08/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2012
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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