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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problem Insufficient Information (3190)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 10/30/2022

Event Type  Injury  

Manufacturer Narrative

The monitor and electrode belt have been returned to the distributor.The evaluations have not yet been completed.Based on the data available at this time, there is no indication of a device malfunction causing or contributing to the delivery of an external defibrillation.

Event Description

Patient received 2 appropriate shocks during ventricular tachycardia (vt) at 210 bpm.The arrhythmias were converted to a slower rhythm of 70 bpm.The lifevest detected vt at 210 bpm for a third time.The response buttons were pressed delaying the treatment.At 34 seconds into the detection sequence an external defibrillation was delivered.The patient was in the hospital prior to, during and after the treatments.No allegation of a death or serious injury.The patient continues to wear the lifevest.

Manufacturer Narrative

Correction: the initial report was filed in error.The distributor has provided corrected information as documented in b3 and b5.There was no adverse event during the appropriate treatments and no intervention.The adverse event has been reported in mfr.Report ref # (b)(4).

Event Description

Patient received 2 appropriate shocks during vt at 220 and 210 bpm.The arrhythmias were converted to a slower rhythm.No adverse event or patient injury was reported.Patient received 2 appropriate shocks during ventricular tachycardia (vt) at 210 bpm.The arrhythmias were converted to a slower rhythm of 70 bpm.The lifevest detected vt at 210 bpm for a third time.The response buttons were pressed delaying the treatment.At 34 seconds into the detection sequence an external defibrillation was delivered.The patient was in the hospital prior to, during and after the treatments.No allegation of a death or serious injury.The patient continues to wear the lifevest.

• 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 Key: 15779319
• MDR Text Key: 303556539
• Report Number: 3008642652-2022-25444
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

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 Number: LIFEVEST WCD 4000 SYSTEM
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 11/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention