MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION UCOR HEART FAILURE AND 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 03/15/2022

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing to iso (b)(4) was successfully completed on skin-contacting surfaces.

Event Description

A us distributor contacted zoll to report that the patient developed a skin irritation from the ucor hfams patch.The patient described the area as red, raised with 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 skin irritation is unknown.

• Brand Name: UCOR HEART FAILURE AND 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: 14015463
• MDR Text Key: 288619074
• Report Number: 3008642652-2022-03530
• 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: K172510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2022

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: 03/16/2022
• Initial Date FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other