• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number WCD 4000
Device Problem Reset Problem (3019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluation of battery charger/modem sn (b)(4) has been completed.The reported problem (resets) was confirmed.Upon investigation the charger/modem was resetting.The charger exhibited a failure at pld component u1003 and pxa component u104 on the c/a board.The root cause for the u1003 and u104 failure could not be positively identified.No adverse event resulted from the defective battery charger/modem.
 
Event Description
A us distributor reported that a charger was resetting.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIFEVEST WCD 4000 SYSTEM
Type of Device
WEARABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh, pa
Manufacturer (Section G)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh, pa
Manufacturer Contact
rachel mahoney
121 gamma drive
pittsburgh, pa 
9683333
MDR Report Key10254787
MDR Text Key198881608
Report Number3008642652-2020-05882
Device Sequence Number1
Product Code MVK
UDI-Device Identifier00855778005029
UDI-Public00855778005029
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 07/08/2020
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
Device Catalogue Number10A0985
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2020
Initial Date Manufacturer Received 06/12/2020
Initial Date FDA Received07/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-