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

Model Number	SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN)
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the sp02 8-pin d-sub-adapter cable 3m indicating that the device is no longer recognized by the monitor, the sp02 curve is gone and they are unable to monitor the patient.The device was in use on a patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer, who supplied audit logs and printouts, which revealed the gap in spo2 measurement from 7:22am to 7:34am.The audit log revealed a technical inop alarm was generated at 7:22am for 'spo2 no sensor' and the alarm was acknowledged at 7:30am.The inop alarm was triggered again at 7:31am after activating the spo2 measurement.At 7:34am, the problem with spo2 appears to have been resolved and the alarm ended.The spo2 cable was replaced to resolve the issue with no actual harm to the patient.Analysis was performed and investigation has been completed.The customer replaced the sensor cable to resolve the issue.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: SPO2 CABLE
• Common Device Name: SPO2 CABLE
• 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: 23547333
• Report Number: 9610816-2025-001064
• Device Sequence Number: 18571515
• Product Code: DQA
• UDI-Device Identifier: 00884838011946
• UDI-Public: (01)00884838011946(10)524
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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: 05/24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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 Age: 5 DA
• Patient Sex: Male
• Patient Weight: 14 KG