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	09/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A us distributor contacted zoll to report that a patient developed an allergic reaction under the lifevest equipment.Patient described the area as red and bumpy under the back te pads.The patient¿s physician confirmed they had an allergic reaction to nickel.There was no alleged device malfunction contributing to reaction.The patient¿s physician prescribed a steroid cream for the reaction.Follow up indicated that the reaction improved.
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: 50944737
• Report Number: 3008642652-2026-09500
• Device Sequence Number: 10446598
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: (01)00855778005005(11)160425
• 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