MAUDE Adverse Event Report: ZOLL Manufacturing Corporation LifeVest WCD 4000 System; Wearable Cardioverter Defibrillator

Model Number	LifeVest WCD 4000 System
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A us distributor reported that a monitor's response buttons were not functioning.
Additional Manufacturer Narrative
Device evaluation of monitor has been completed.The reported problem (response buttons non-functional) was confirmed.Upon investigation, the rear response button was not functional.As received, the rear response button trace was creased.The cause of the non-functional response buttons is the damaged trace.The root cause of the creased trace cannot be positively identified.No adverse event resulted from the damaged monitor.

• 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 15238
• Manufacturer Contact: zoll mfg corporation ; 121 gamma drive; pittsburgh, PA 15238
• MDR Report Key: 50949374
• Report Number: 3008642652-2026-09541
• Device Sequence Number: 10452093
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: (01)00855778005005(11)200909
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: LifeVest WCD 4000 System
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/30/2026
• 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
• Patient Sex: Unknown