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

Model Number	LIFEVEST WCD 4000 SYSTEM
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	10/05/2024
Type of Reportable Event	Death
Additional 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 or Problem Description
A us distributor contacted zoll to report that a patient passed away on (b)(6) 2024 while reportedly wearing the lifevest.The patient received three inappropriate treatments and a non-lifevest defibrillation.The device was started up at 19:32:12 on (b)(6) 2024.At 22:53:09, an arrhythmia was detected.Ecg shows svt @ 150 bpm with motion/tactile artifact and electrode lead falloff.At 22:54:22, the patient received the first inappropriate treatment.Svt contributed to the false detection.Rhythm at the time of treatment was svt @ 150 bpm with motion artifact and electrode lead falloff.Post shock rhythm was svt @ 150 bpm with motion artifact and electrode lead falloff.At 22:54:41, the patient received the non-lifevest defibrillation.The rhythm at the time of the non-lifevest defibrillations was svt @ 150 bpm.Post shock rhythm was svt @ 150 bpm with motion/tactile artifact and electrode lead falloff.At 22:55:52, the patient received the second inappropriate treatment.Svt contributed to the false detection.Rhythm at the time of treatment was svt @ 150 bpm with motion artifact and electrode lead falloff.Post shock rhythm was svt @ 150 bpm with motion artifact and electrode lead falloff.At 22:56:19, the patient received the third inappropriate treatment.Svt contributed to the false detection.Rhythm at the time of treatment was svt @ 160 bpm with motion artifact and electrode lead falloff.Post shock rhythm was svt @ 160 bpm with motion artifact and electrode lead falloff.The electrode belt was disconnected at 22:56:29 on (b)(6) 2024.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Common Device Name: 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: 20612273
• Report Number: 3008642652-2024-10985
• Device Sequence Number: 7854989
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: (01)00855778005005(11)170928
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: P010030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: LIFEVEST WCD 4000 SYSTEM
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/05/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown