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

Model Number 02-01894

Device Problem Excessive Heating (4030)

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

Event Type  malfunction  

Event Description

The patient reported that the monitor charging plug was hot to the touch and caused damaged to their wall outlet.The patient stated that the powerstrip that they plugged the charger into no longer works.There was no patient harm reported.The device is expected to be returned and a replacement kit was sent.

Manufacturer Narrative

It was reported that when the mcot monitor was plugged in it became hot to the touch and messed the patient's outlet.The device was not returned for investigation.Engineering evaluation was unable to be performed as the wall charger was not returned.Patient noted the use of a "power strip".Per the philips patient education guide the device is to be plugged into a singular outlet and extension cords or power strips should not be used.Unable to confirm allegation as evidence was not provided.Root cause unknown.Monitor sn: (b)(6)| bom: 02-02118 | udi: (b)(4) was present during the time of the event although it is not thought to have caused or contributed to the allegation as the event happens between the wall charger and the outlet.

• 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: 17730134
• MDR Text Key: 323195645
• Report Number: 2133409-2023-00054
• 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: 03/20/2024

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: 02-01894
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• 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: MONITOR CHARGER, 700-0719-01
• Patient Age: 63 YR
• Patient Sex: Female