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

Model Number HFAMS

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 08/21/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A zoll laboratory services contacted zoll to report that a patient developed an irritation mostly around the patch.The patient reported the irritation was broken skin, red, and raised skin.There was no alleged device malfunction contributing to the irritation.Patient was using an antibiotic and the device was discontinued due to irritation by the healthcare provider.Outcome of the 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 3495
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer Contact: kevin chan ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 12489491
• MDR Text Key: 271962052
• Report Number: 3008642652-2021-08109
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2021

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: HFAMS
• Device Catalogue Number: 10A1067
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/17/2021
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention