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

Model Number UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/28/2023

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing to iso 10993 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.Patient described the area as broken skin with burning, bleeding, and sharp pain under the patch adhesive.There was no alleged device malfunction contributing to the irritation.There is no indication that the patient received medical intervention.

• Brand Name: UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM
• Type of Device: 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: 18418198
• MDR Text Key: 331587805
• Report Number: 3008642652-2023-13053
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• 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: 12/29/2023

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: UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 12/29/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1