MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH SPO2 CABLE; SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN)

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	11/18/2025
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
Additional information was requested to verify the disposition of the device for analysis; however, the disposition is unknown.No analysis was able to be performed.The product malfunction was unable to be confirmed because the device was not available for analysis.No further information is available.A replacement device was sent to the customer under warranty.Based on the information available and results of additional analysis, no further action is necessary at this time.If additional information is received, the complaint file will be reopened for further investigation.

• Brand Name: SPO2 CABLE
• Common Device Name: SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN)
• 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: 23830582
• Report Number: 9610816-2025-001246
• Device Sequence Number: 18463774
• Product Code: DQA
• UDI-Device Identifier: 00884838011946
• UDI-Public: (01)00884838011946(10)05-2025
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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 Model Number: SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN)
• Device Catalogue Number: 989803128651
• Device Lot Number: 05-2025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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