MAUDE Adverse Event Report: ZOLL Manufacturing Corporation LifeVest WCD 5100 System; Wearable Cardioverter Defibrillator

Model Number	LifeVest WCD 5100 System
Medical Device Problem Codes	Structural Problem (2506); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A us distributor returned a monitor and reported that the response buttons were non-functional.
Event or Problem Description
A us distributor reported that an electrode belt was unable to securely latch to a monitor.
Additional Manufacturer Narrative
Device evaluation of monitor has been completed.The reported problem (response buttons non-functional) was due to the response button switch was broken.The root cause of the broken switch cannot be positively identified.There was no adverse event that resulted from the damaged monitor.
Additional Manufacturer Narrative
Device evaluation of electrode belt has been completed.The reported problem (unable to securely latch to a monitor) has been confirmed.Upon evaluation of the electrode belt, the trunk cable connector was damaged and was unable to connect to a monitor.The root cause for the damaged connector could not be positively identified.There was no adverse event that resulted from the damaged belt.

• Brand Name: LifeVest WCD 5100 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: 50591216
• Report Number: 3008642652-2026-08550
• Device Sequence Number: 9451056
• Product Code: MVK
• UDI-Device Identifier: 00855778005388
• UDI-Public: (01)00855778005388(17)280403
• 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,Followup
• Report Date (Section B): 09/16/2026

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 5100 System
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/16/2026
• 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