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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 Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2015
Event Type  malfunction  
Event Description
A us distributor returned a battery pack indicating that it was non-functional.
 
Manufacturer Narrative
Device evaluation of battery pack sn (b)(4) has been completed.The reported problem (non-functional) was confirmed.As received, the battery was non-functional when placed into a monitor and charger.Upon evaluation, the output voltage was 1.28v.The cause of the non-functional battery is the lack of output voltage.The cause of the lack of output voltage is defective cells.The root cause of the defective cells cannot be positively identified.No adverse event resulted from the defective battery pack.
 
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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 349
Manufacturer (Section G)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA 15238 349
Manufacturer Contact
katelynn mains
121 gamma drive
pittsburgh, PA 15238-3495
4129683333
MDR Report Key4946305
MDR Text Key20070329
Report Number3008642652-2015-04638
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 07/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2015
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 Manufacturer07/02/2015
Date Manufacturer Received07/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2014
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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