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

Model Number	LifeVest WCD 4000 System
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	09/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A us distributor contacted zoll to report that a patient developed a skin irritation under the lifevest equipment.Patient described the area as a rash under the shoulder straps and garment.The patient also reported a history of skin sensitivity or allergies, and lupus.There was no alleged device malfunction contributing to the irritation.The patient¿s dermatologist prescribed a medication for the skin irritation.Outcome of the irritation is unknown.
Additional Manufacturer Narrative
Not applicable.

• 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: 50947306
• Report Number: 3008642652-2026-09526
• Device Sequence Number: 10451638
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: (01)00855778005005(11)110131
• 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?: Yes
• Is this a Product Problem Report?: No
• 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: 09/30/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown