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

Model Number WCD 4000

Device Problem Signal Artifact/Noise (1036)

Patient Problems Bradycardia (1751); Ventricular Fibrillation (2130)

Event Date 03/16/2022

Event Type  Death  

Manufacturer Narrative

The electrode belt and monitor have 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 while wearing the lifevest on (b)(6) 2022.Review of the download data, indicates the patient received three appropriate treatments during vt/vf which converted the arrythmia to a slower rhythm.At 00:24:20, the patient received the first appropriate treatment.The patient's rhythm at the time of the treatment event was vt @ 210 bpm with motion artifact.The patient's post-shock rhythm was sinus tachycardia @ 100 bpm with pvcs and motion artifact.At 00:27:23, the patient received the second appropriate treatment.The patient's rhythm at the time of the treatment event was vf with motion artifact.The patient's post-shock rhythm was vt @ 240 bpm with motion artifact.At 00:27:58, the patient received the third appropriate treatment.The patient's rhythm at the time of the treatment event was vf with motion artifact.The patient's post-shock rhythm was asystole with intermittent cardiac activity and motion artifact for 15 seconds transitioning to sinus bradycardia @ 30 bpm with pvcs and hb.At 00:47:47, electrode belt was disconnected.Patient was last seen in bradycardia.The patient passed away on (b)(6) 2022.Reporting due to post-shock asystole on third treatment.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer Contact: steven kyle ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 13905000
• MDR Text Key: 287926677
• Report Number: 3008642652-2022-03055
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• 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: 03/24/2022

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: WCD 4000
• Device Catalogue Number: 10A0988
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death