Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL LIFECOR 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 LIFECOR CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number WCD 4000
Device Problems Melted (1385); Sticking (1597)
Patient Problem No Information (3190)
Event Date 03/29/2014
Event Type  malfunction  
Event Description
A (b)(6) female patient's daughter contacted zoll customer support to report that the patient's battery was melted and stuck in the charger.The patient was issued a replacement battery pack.
 
Manufacturer Narrative
Device evaluation summary: device evaluation of batter pack sn (b)(4) has been completed.The reported problem (damaged battery casing) has been confirmed.Upon receipt of the battery casing was burnt and the battery pack was shorted.The root cause for the burnt case and shorted battery pack cannot be positively determined but may have been caused by ingress of an unknown contaminant.No adverse event resulted from the defective battery pack.The patient received a replacement battery pack.
 
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 LIFECOR CORPORATION
pittsburgh PA 15238 349
Manufacturer Contact
samantha beckowski
121 gamma dr
pittsburgh, PA 15238-3495
4129683333
MDR Report Key3823645
MDR Text Key4500620
Report Number3008642652-2014-01345
Device Sequence Number1
Product Code MVK
Combination Product (y/n)N
PMA/PMN Number
P010030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Remedial Action Replace
Type of Report Initial
Report Date 04/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2014
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 Manufacturer04/03/2014
Date Manufacturer Received04/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2014
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age75 YR
-
-