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	08/29/2025
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 broken skin irritation under the patch.The patient described the area as red, itchy broken skin.The patient stated they do have a history of sensitive skin and /or allergies.There was no alleged device malfunction contributing to the irritation.There is no indication that the patient received medical intervention.The outcome of the irritation is unknown.

• 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: 22990864
• Report Number: 3008642652-2025-08571
• Device Sequence Number: 18546570
• Product Code: MHX
• UDI-Device Identifier: 00855778005357
• UDI-Public: (01)00855778005357(11)200330
• 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): 09/08/2025

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: 09/07/2025
• Initial Report FDA Received Date: 09/08/2025
• 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