MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC CHARGE ADPTR ASSY,BTP-1000S-CA

Device Problems Electrical /Electronic Property Problem (1198); Failure to Run on Battery (1466)

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

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

A replacement charger was sent to the patient to continue enrollment.

Event Description

The patient contacted biotel heart patient services to report that the wires on his sensor charger were exposed and the sensor would not charge.The patient was not shocked or harmed in any fashion.

Manufacturer Narrative

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.

• Brand Name: CHARGE ADPTR ASSY,BTP-1000S-CA
• Type of Device: CHARGE ADPTR ASSY,BTP-1000S-CA
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center dr; suite 150; eagan MN 56121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6124263781
• MDR Report Key: 15568645
• MDR Text Key: 306622690
• Report Number: 2133409-2022-00011
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male