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

Model Number	SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN)
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on an sp02 8-pin d-sub adapter cable 3m (8pin) indicating that the spo2 cord will not work.No matter the patient or position, the cord relays a weak pleth signal or no signal and the o2 is always reported low.The device was in use on a patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Analysis of the returned cable was performed by the hpm medical consumables & sensor investigator at the philips failure analysis lab.The evaluation included visual inspection, electrical testing, and functional performance testing to reproduce the reported issue.Visual inspection found that the cable has no visible physical damage.The cable could not produce a steady signal, the voltage test on pins from the 9-pin connector pin 6 to the 8-pin connector pin 1 showed no voltage reading using a hp e2377a multimeter.Functional testing was performed using an intellivue x3, as well as using a ox-sim spo23 simulator, a m1196t and m1191b spo2 sensor, and hp e2377a multimeter.Confirming the test with an et58757 test box and a fluke 115 true rms multimeter showed voltage outside the tolerance, 6.55 to 6.77 k ohms.It was also noted that twisting of the cable causes the inner ground shield to separate causing the voltage to change.Based on these findings, the adapter cable did not perform as designed, and the customer¿s complaint was confirmed.

• Brand Name: SPO2 CABLE
• Common Device Name: OXIMETER
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 25432496
• Report Number: 9610816-2026-101105
• Device Sequence Number: 13346197
• Product Code: DQA
• UDI-Device Identifier: 00884838011946
• UDI-Public: (01)00884838011946(10)0424
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K032979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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 Model Number: SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN)
• Device Catalogue Number: 989803128651
• Device Lot Number: 0425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown