MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH SPO2 CABLE; OXIMETER

Model Number	SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Spo2 [peripheral oxygen saturation] adapter cable failed to transmit data from pulse oximeter finger probe to monitor.This caused a delay in patient care because the adapter cable had to be replaced in order to obtain a reading.

• Brand Name: SPO2 CABLE
• Common Device Name: OXIMETER
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; 222 jacobs street; cambridge MA 02140
• MDR Report Key: 22884950
• Report Number: 22884950
• Device Sequence Number: 8790368
• Product Code: DQA
• UDI-Device Identifier: 00884838011946
• UDI-Public: (01)00884838011946
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/18/2025
• Report Date (Section F): 08/18/2025

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
• Device Model Number: SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN)
• Device Catalogue Number: 989803128651
• Device Lot Number: 325
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 08/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/18/2025