MAUDE Adverse Event Report: ABBOTT MEDICAL ORION RC CHARGER; SCS CHARGER

Model Number	16000
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is estimated.
Event or Problem Description
It was reported patient noticed that when charger was plugged in charger gets hot quickly and smells of something burning.They have also noted black dots appearing on the blue label.As such the charger was replaced.
Additional Manufacturer Narrative
The reported event of charger heating while charging the charger was not confirmed.Communication and functional testing confirmed the charger functioned as designed.The field scenario was recreated to address the issue of charger heating while charging the charger.The patient¿s power adapter and charging cable was not returned for analysis.The charger met the product requirement specification for heat generation during use.

• Brand Name: ORION RC CHARGER
• Common Device Name: SCS CHARGER
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 21687700
• Report Number: 1627487-2025-01433
• Device Sequence Number: 8850133
• Product Code: PCW
• UDI-Device Identifier: 05415067040756
• UDI-Public: (01)05415067040756(10)10471587(17)260809
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2026
• Device Model Number: 16000
• Device Catalogue Number: 16000
• Device Lot Number: 10471587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 113 KG