MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC DUAL USB CHARGING PLUG

Model Number 700-0718-01

Device Problems Melted (1385); Smoking (1585); Excessive Heating (4030)

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

Event Date 06/19/2023

Event Type  malfunction  

Event Description

The patient's husband called and reported that the charger for the monitor was plugged into the wall with nothing, plugged into the wall with nothing, plugged into it and it started smoking and melted.The patient's husband stated that they just got home and saw the charger smoking.The charger was removed from wall and returned.The patient or patient's husband were not injured.

Event Description

The patient's husband called and reported that the charger for the monitor was plugged into the wall with nothing plugged into the wall with nothing plugged into it and it started smoking and melted.The patient's husband stated that they just got home adn saw the charger smoking.The charger was removed from wall and returned.The patient or patient's husband were not injured.

Manufacturer Narrative

The patient reported that the charger for monitor was plugged into the wall with nothing plugged with it and it started smoking and melted.The device was not returned for investigation.We are doing further investigation for mcto usb-a/ usb-c cables overheating.

• Brand Name: DUAL USB CHARGING PLUG
• Type of Device: DUAL USB CHARGING PLUG
• 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: 17324675
• MDR Text Key: 319942586
• Report Number: 2133409-2023-00039
• 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: 08/09/2023

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: 06/18/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 700-0719-01, MICRO-USB CHARGING CORD; 700-0719-01, MICRO-USB CHARGING CORD
• Patient Age: 26 YR
• Patient Sex: Female