• 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 Over-Sensing (1438)
Patient Problem Arrhythmia (1721)
Event Date 12/25/2023
Event Type  Death  
Manufacturer Narrative
Device evaluation of the monitor and electrode belt has been completed.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the tactile vibration alarm, audio messaging, and siren alarms, as well as a test of the pulse delivery circuitry.The pulse delivery circuitry test verified proper charging of the high voltage capacitors and proper delivery of five full energy 150j biphasic pulses.The functional testing confirmed proper response button functionality, ecg acquisition, detection algorithm performance, and pulse delivery functionality.There is no indication of a product malfunction.
 
Event Description
A us distributor contacted zoll to report that a patient passed away on (b)(6) 2023 while reportedly wearing the lifevest.The patient received four inappropriate treatments.The device was started up at 12:56:05 on (b)(6) 2023.At 13:20:46, an arrhythmia was detected.Ecg shows idioventricular rhythm @ 80 bpm with cpr/motion artifact.At 13:21:55, the patient received the first inappropriate treatment.Cpr/motion artifact contributed to the false detection.The rhythm at the time of treatment was idioventricular rhythm @ 80 bpm with cpr/motion artifact.Post shock rhythm was idioventricular rhythm @ 80 bpm with cpr/motion artifact.At 13:22:27, the patient received the second inappropriate treatment.Cpr/motion artifact contributed to the false detection.The rhythm at the time of treatment was idioventricular rhythm @ 70 bpm with cpr/motion artifact.Post shock rhythm was idioventricular rhythm @ 80 bpm with cpr/motion artifact.At 13:22:58, the patient received the third inappropriate treatment.Cpr/motion artifact contributed to the false detection.The rhythm at the time of treatment was idioventricular rhythm @ 80 bpm with cpr/motion artifact.Post shock rhythm was idioventricular rhythm @ 80 bpm with cpr/motion artifact.At 13:23:42, the patient received the fourth inappropriate treatment.Cpr/motion artifact contributed to the false detection.The rhythm at the time of treatment was obscured due to cpr/motion artifact.Post shock rhythm recorded cpr/motion artifact transitioning to vt @ 140 bpm.The device was shut down at 13:27:18 on (b)(6) 2023.
 
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 Key18771099
MDR Text Key336138034
Report Number3008642652-2024-02098
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 Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/23/2024
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 01/30/2024
Initial Date FDA Received02/23/2024
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) Death;
-
-