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

Model Number	LifeVest WCD 5100 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	02/18/2026
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
During investigation of the monitor on a reportable malfunction was found.The monitors response button was difficult to activate due to contaminated.The cause of the inability to activate the monitor is the contaminated response button.The root cause of the contaminated response button is liquid ingress of an unknown contaminant.Lifevest patient training materials have been updated as a reminder not to expose lifevest electronic components to liquid.No adverse event resulted from the damaged monitor.

• 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: 50791265
• Report Number: 3008642652-2026-09032
• Device Sequence Number: 9443121
• Product Code: MVK
• UDI-Device Identifier: 00855778005371
• UDI-Public: (01)00855778005371(11)240404
• 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): 09/16/2026

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: 09/16/2026
• Initial 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