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

Model Number 700-0718-01

Device Problems Break (1069); Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Manufacturer Narrative

The patient reported that the charger plug was plugged into the outlet and broke when the patient went to remove it from the wall.The device was not retrurned.The cause of the issue was the supplier usage of an ultrasonic welding tool that was not effective due to it being limited to the number of cycles it could be used to manufacture the component.This caused an inconsistent weld pattern on the component.A user cannot detect if the welded joint is adequate and has no indication the device may fail during normal use.When the failure occurs, the wall adapter separates into two pieces.The user can easily detect this event and at this point the device is no longer functional and cannot be used.Philips am&d are continuing to monitor the issue.

Event Description

Patient called in because she had the monitor charger plugged into the wall.She went to pull it out and the prongs have gotten stuck in the outlet.Patient got it out of outlet, but needs replacement charger.A replacement charger was sent.No patient harm was reported.

• 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: 18150850
• MDR Text Key: 328766001
• Report Number: 2133409-2023-00074
• 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
• Report Date: 11/16/2023

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: 700-0718-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2023
• Initial Date FDA Received: 11/16/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Female