MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT PPM

Model Number 02-01548

Device Problems Overheating of Device (1437); Sparking (2595)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2024 that the patient was unable to charge to the monitor.The monitor sparked and popped and the charging cord was melted.The monitor was plugged in to the wall outlet at the time of the event and tripped the breaker.The patient reoplrted that after this happened they attempted to charger the monitor with their personal phone cord.The patient services rep advised the patient to not user their personal charging cord and that they should only use what was provided to them in the kitted box.The patient was advised of return instructions to return the charging cord and monitor.A replacement was order.No patient injuries were reported.

Manufacturer Narrative

It was reported the c6 mcot monitor propped and sparked and melted the plug and blew the patient's breaker.The device was returned for investigation.C6 mcot monitor was inspected for general physical integrity; no problems were identified.The charger was not returned with the monitor.Charging port is intact and device was able to charge with no issue.Engineering evaluation was unable to replicate the reported allegation of "patient then stated the monitor popped, sparked and melted the plug".All temperature thresholds were within tolerance and the application was functioning properly; device was able to charge to 100%; no problems found.As the monitor was identified to be in working order, any alleged spark is most probable to come from the charging cord for which there is a known issue that aligns with the failure mode and is being further investigated by philips am&d.

• Brand Name: C6 MCOT PPM
• Type of Device: C6 MCOT PPM
• 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: 18828508
• MDR Text Key: 337734670
• Report Number: 2133409-2024-00013
• 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: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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: 02-01548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2020
• 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: CHARGER CORD, RED A10E PHONE, 700-0770-01.
• Patient Age: 52 YR
• Patient Sex: Female