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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 Problems Device Stops Intermittently (1599); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/01/2015
Event Type  malfunction  
Manufacturer Narrative
Device evaluation of monitor sn (b)(4) has been completed.The reported problem (belt communication faults / multiple abnormal shutdowns) was confirmed.Upon evaluation, the u104 (pxa) component was intermittent on ca board sn (b)(4).Root cause investigation is underway on devices exhibiting similar failure modes.No adverse event resulted from the defective monitor.
 
Event Description
A us distributor contacted zoll to report that a patient's monitor was producing belt communication faults and 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
katelynn mains
121 gamma drive
pittsburgh, PA 15238-3495
4129683333
MDR Report Key5273106
MDR Text Key33327775
Report Number3008642652-2015-07853
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 12/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2015
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 Manufacturer11/03/2015
Date Manufacturer Received11/16/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2014
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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