MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION ARRHYTHMIA MANAGEMENT SYSTEM; MANAGEMENT AND MONITOR SYSTEM, PRODUCT CODE MHX

Model Number	Patch
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	02/26/2022
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 hydrogel circles.The patient reported burning, broken skin.There was no alleged device malfunction contributing to the irritation.There is no indication that the patient received medical intervention.Outcome of the irritation is unknown.

• Brand Name: ARRHYTHMIA MANAGEMENT SYSTEM
• Common Device Name: MANAGEMENT AND MONITOR SYSTEM, PRODUCT CODE MHX
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer Contact: stephanie cowan ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 13829498
• Report Number: 3008642652-2022-02712
• Device Sequence Number: 16470907
• Product Code: MHX
• UDI-Device Identifier: 00855778005258
• UDI-Public: 00855778005258
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2022

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: Patch
• Device Catalogue Number: 10A1067
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown