MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION ARRHYTHMIA MANAGEMENT SYSTEM; MANAGEMENT AND MONITOR SYSTEM

Model Number	ARRHYTHMIA MANAGEMENT SYSTEM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces.
Event or Problem Description
Zoll laboratory services contacted zoll to report that a patient developed a skin irritation under the patch.Patient described the area as skin irritation.There was no alleged device malfunction contributing to the irritation.The patient reported seeing physician, but there is no indication of medical intervention, reporting out of abundance of caution.Outcome of the irritation is unknown as follow-ups were unsuccessful.

• Brand Name: ARRHYTHMIA MANAGEMENT SYSTEM
• Common Device Name: MANAGEMENT AND MONITOR SYSTEM
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA
• Manufacturer Contact: zoll mfg corporation ; 121 gamma drive; pittsburgh, PA 15238
• MDR Report Key: 22326899
• Report Number: 3008642652-2025-06142
• Device Sequence Number: 15811672
• Product Code: MHX
• UDI-Device Identifier: 00855778005357
• UDI-Public: (01)00855778005357(11)210128
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K190939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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: ARRHYTHMIA MANAGEMENT SYSTEM
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/25/2025
• 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