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 04/25/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Hfams patch.The patient described the area as red and burning.There was no alleged device malfunction contributing to the irritation.The patient reported reaching out to the physician, but there is no indication of medical intervention.Reporting out of an abundance of caution.The outcome of the skin irritation is unknown.

• 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: 19212276
• MDR Text Key: 341370994
• Report Number: 3008642652-2024-04445
• 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: 04/30/2024

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: 04/30/2024
• Initial Date FDA Received: 04/30/2024
• 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