MAUDE Adverse Event Report: ORANTECH INC. ORANTECH; CABLE, ELECTRODE

Model Number	SA-015RB-30
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While setting up the intensive care unit (icu) room, noted that the plastic cover that protects the oxygen saturation (spo2) adapter end to the patient was missing, presumed broken and discarded.

• Brand Name: ORANTECH
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): ORANTECH INC.; 1 technology dr. suite b115; irvine CA 92618
• MDR Report Key: 20586982
• Report Number: 20586982
• Device Sequence Number: 8797376
• Product Code: IKD
• UDI-Device Identifier: 06941691962656
• UDI-Public: (01)06941691962656
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2024
• Report Date (Section F): 08/21/2024

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 Model Number: SA-015RB-30
• Device Lot Number: 1240418010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 11/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/21/2024