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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bradycardia (1751); Asystole (4442)

Event Date 01/21/2023

Event Type  Injury  

Event Description

The patient was appropriately treated 3 times by the lifevest.The patient received 1 additional inappropriate treatment.At 04:12:40, the patient received the first appropriate treatment.The patient's rhythm at the time of the treatment event was vf.The patient's post-shock rhythm was asystole transitioning to severe bradycardia @ 10 bpm.The rhythm then degrades to vt @ 280 bpm.At 04:13:47, the patient received the second appropriate treatment.The patient's rhythm at the time of the treatment event was vf.The patient's post-shock rhythm was sinus bradycardia @ 40 bpm with pvc¿s.The rhythm then degrades to vf.At 04:14:55, the patient received the third appropriate treatment.The patient's rhythm at the time of the treatment event was vf.The patient's post-shock rhythm was asystole at 04:16:02, the patient received the first inappropriate treatment.The patient's rhythm at the time of the treatment event was asystole.The patient's post-shock rhythm was sinus bradycardia @ 30 bpm.Post shock asystole is a known and potentially adverse outcome of defibrillation therapy.The response buttons were not pressed during the event.The patient went to the hospital for further evaluation.Patient will continue to wear lifevest.

Manufacturer Narrative

Electrode belt and monitor were not recovered from the field.Device evaluation included review of downloaded software flag files on the day of the event.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction that would contribute to the event.

• 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: 16356557
• MDR Text Key: 309323103
• Report Number: 3008642652-2023-01239
• 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
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• 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
• Date Manufacturer Received: 01/23/2023
• 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): Hospitalization