• 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 LIFEVEST WCD 4000 SYSTEM
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 11/10/2022
Event Type  Injury  
Manufacturer Narrative
The monitor and electrode belt have not been returned to the distributor.Based on the data available at this time, there is no indication of a device malfunction causing or contributing to the treatment.The ecg and flag data surrounding the alleged treatment was unavailable for review due to the patient not having all of the lifevest equipment with them to perform a download.Awaiting return of monitor and electrode belt for evaluation.
 
Event Description
A us distributor was contacted on 11/10/2022 by a physician calling from the hospital to report that a patient experienced a defibrillation event.The ecg and flag data surrounding the alleged treatment was unavailable.Zoll is unable to positively determine if the defibrillation treatment occurred and if it was an appropriate or inappropriate treatment.There was no death or serious injury reported with the alleged defibrillation event.
 
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 15238
Manufacturer (Section G)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA
Manufacturer Contact
zoll mfg corporation
121 gamma drive
pittsburgh, PA 15238
MDR Report Key15815046
MDR Text Key303848293
Report Number3008642652-2022-25657
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 11/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberLIFEVEST WCD 4000 SYSTEM
Initial Date Manufacturer Received 11/14/2022
Initial Date FDA Received11/17/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
-
-