MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT PPM; UNIT,J3 S 2018

Model Number 02-01549

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

It was reported that the monitor was charging and the monitor charger melted into the monitor.The device was returned for investigation.Device cannot be tested for heat stress test due to the charging cord being melted in device.Am&d philips is doing further investigation of this reportred malfunction.

Event Description

It was reported on 02 january 2023 by the nurse at the hospital that they were charging the monitor and the charger melted.The nurse noted that the charger melted into the phone.A replacement was ordered, and the device was requested to be returned.There was no report of patient or user injury.

• Brand Name: C6 MCOT PPM
• Type of Device: UNIT,J3 S 2018
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121
• MDR Report Key: 18468605
• MDR Text Key: 332613029
• Report Number: 2133409-2024-00001
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02-01549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MICRO-USB CHARGING CORD, 700-0719-01.
• Patient Age: 44 YR
• Patient Sex: Male