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

Model Number 02-02118

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Noise, Audible (3273)

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

Event Date 03/08/2024

Event Type  malfunction  

Event Description

It was reported on 15 march 2024 on (b)(6) 2024 the patient went to plug in the mcot monitor - a13 - verizon to charge and noted that they heard a sizzling sound.They also reported, that the monitor was very hot adn smelled like burning electricity.It was confirmed that the monitor was plugged into the outlet only.The patient also reported that the damage was noted on the charging wall plug only.No pictures were not taken.A replacement was order.No injuries were reported.

Manufacturer Narrative

It was reported the c6 mcot monitor was plugged in and charging and it made a sizzling sound and the monitor smelt like burning electricity.The monitor was returned for investigation.C6 mcot monitor was inspected for general physical integrity; no problems were identified.Engineering evaluation was unable to replicate the reported allegation of "monitor is getting too hot to touch".All temperature thresholds were within tolerance and the application was functioning properly; no problems found.No damage was found on the monitor due to the melted charging cord.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 that is being investigated by philips am&d.

• Brand Name: C6 MCOT PPM
• Type of Device: MCOT MONITOR
• 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: 19032524
• MDR Text Key: 340115903
• Report Number: 2133409-2024-00024
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146C6M90
• UDI-Public: B146C6M90
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 02-02118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CHARGING CABLE - MONITOR - A TO MICRO-B, 700-071
• Patient Age: 25 YR
• Patient Sex: Female