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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 LIFEVEST WCD 4000 SYSTEM
Device Problem Signal Artifact/Noise (1036)
Patient Problems Atrial Fibrillation (1729); Bradycardia (1751); Tachycardia (2095); Ventricular Fibrillation (2130)
Event Date 04/07/2022
Event Type  Death  
Manufacturer Narrative
The monitor has been returned and the evaluation is underway.The device flag data from the last download does not indicate any device malfunction.The electrode belt has not been recovered.The device flag data from the last download does not indicate any device malfunction.
 
Event Description
A us distributor contacted zoll to report that a patient passed away on (b)(6) 2022 while reportedly wearing the lifevest.The patient received an appropriate treatment and four non-lifevest treatments.The device was started up at 10:23:39 on (b)(6) 2022.From 15:58:50 to 16:00:59, the patient was af @ 100 bpm with pvc¿s.The rhythm degrades to vf with motion artifact and varying heart rate.From 15:59:10 to 16:15:08, vf was seen intermittently.Varying amplitudes, cpr/motion artifact and electrode lead fall off prevented the lifevest from treating the patient at 16:00:59, the patient received the first non-lifevest treatment.The rhythm at the time of the non-lifevest defibrillations was vf with cpr/motion artifact.Post shock rhythm was vf with cpr/motion artifact.At 16:03:45, the patient received the second non-lifevest treatment.The rhythm at the time of the non-lifevest defibrillations was vf with motion artifact.Post shock rhythm was vt @ 130 bpm/vf with motion artifact.At 16:05:24, an arrhythmia was detected.Ecg shows vf with cpr/motion artifact.At 16:06:01, the patient received the appropriate treatment.The rhythm at the time of treatment was vf with cpr/motion artifact.The post shock rhythm was sinus bradycardia @ 30 bpm.At 16:10:37, the patient received the third non-lifevest treatment.The rhythm at the time of the non-lifevest treatment was vf with cpr/motion artifact.Post shock rhythm was sinus bradycardia @ 25 bpm with cpr/motion artifact.At 16:15:09, the patient received the fourth non-lifevest treatment.The rhythm at the time of the non-lifevest treatment was vf with cpr/motion artifact.Post shock rhythm was sinus bradycardia @ 20 bpm with cpr/motion artifact.The electrode belt was disconnected at 16:26:02 on (b)(6) 2022.Per holter monitor the patient was last seen in sinus bradycardia @ 20 bpm.The patient passed away on (b)(6) 2022.
 
Event Description
A us distributor contacted zoll to report that a patient passed away on 4/7/2022 while reportedly wearing the lifevest.The patient received an appropriate treatment and four non-lifevest treatments.  the device was started up at 10:23:39 on 4/7/2022.From 15:58:50 to 16:00:59, the patient was af @ 100 bpm with pvc¿s.The rhythm degrades to vf with motion artifact and varying heart rate.From 15:59:10 to 16:15:08, vf was seen intermittently.Varying amplitudes, cpr/motion artifact and electrode lead fall off prevented the lifevest from treating the patient at 16:00:59, the patient received the first non-lifevest treatment.The rhythm at the time of the non-lifevest defibrillations was vf with cpr/motion artifact.Post shock rhythm was vf with cpr/motion artifact.At 16:03:45, the patient received the second non-lifevest treatment.The rhythm at the time of the non-lifevest defibrillations was vf with motion artifact.Post shock rhythm was vt @ 130 bpm/vf with motion artifact.At 16:05:24, an arrhythmia was detected.Ecg shows vf with cpr/motion artifact.At 16:06:01, the patient received the appropriate treatment.The rhythm at the time of treatment was vf with cpr/motion artifact.The post shock rhythm was sinus bradycardia @ 30 bpm.At 16:10:37, the patient received the third non-lifevest treatment.The rhythm at the time of the non-lifevest treatment was vf with cpr/motion artifact.Post shock rhythm was sinus bradycardia @ 25 bpm with cpr/motion artifact.At 16:15:09, the patient received the fourth non-lifevest treatment.The rhythm at the time of the non-lifevest treatment was vf with cpr/motion artifact.Post shock rhythm was sinus bradycardia @ 20 bpm with cpr/motion artifact.The electrode belt was disconnected at 16:26:02 on 4/7/2022.Per holter monitor the patient was last seen in sinus bradycardia @ 20 bpm.The patient passed away on 4/7/2022.
 
Manufacturer Narrative
The monitor has been returned and the evaluation is underway.The device flag data from the last download does not indicate any device malfunction.The electrode belt has not been recovered.The device flag data from the last download does not indicate any device malfunction.
 
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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
Manufacturer (Section G)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA
Manufacturer Contact
zoll mfg corporation
121 gamma drive
pittsburgh, PA 15238
MDR Report Key14652805
MDR Text Key293689786
Report Number3008642652-2022-20241
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,Followup
Report Date 06/16/2022
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
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/09/2022
Initial Date FDA Received06/10/2022
Supplement Dates Manufacturer Received06/13/2022
Supplement Dates FDA Received06/16/2022
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) Death;
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