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

Model Number Patch

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/26/2021

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces.

Event Description

Zoll laboratory services contacted zoll to report that a patient developed itchy hives, redness and black skin under the patch.There was no alleged device malfunction contributing to the irritation.The patient's physician advised discontinuation of the patch due to the skin irritation.Outcome of the skin irritation is unknown.

• Brand Name: ARRHYTHMIA MANAGEMENT SYSTEM
• Type of Device: 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: 13227474
• MDR Text Key: 283619654
• Report Number: 3008642652-2022-00409
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00855778005258
• UDI-Public: 00855778005258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: Patch
• Device Catalogue Number: 10A1067
• Initial Date Manufacturer Received: 12/27/2021
• Initial Date FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention