MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH REUSABLE CLIP ADULT SPO2 SENSOR

Model Number	REUSABLE CLIP ADULT SPO2 SENSOR
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).A philips remote service engineer (rse) interviewed the customer and then dispatched a philips field service engineer (fse) onsite for further evaluation.The fse detected a signal failure in the oxygen saturation sensor model: m1196a with batch number: in623 69657, and so the fse replaced the defective sensor to resolve the issue.The fse carried out the necessary checks to certify the restoration to pre-fault operating conditions.The fse recommended the customer only use philips-approved accessories and consumables to ensure proper operation of the equipment.A good faith effort (gfe) response confirmed the customer was using philips fast technology.Based on the information available and the testing conducted, the cause of the reported problem was confirmed to be the defective fast sensor.The reported problem was confirmed.If additional information is received the complaint file will be reopened.No further investigation or action is warranted at this time.
Event or Problem Description
The customer reported the pulse oximeter of the tower does not pick up well, it tends to pick up downwards.The device was in use on a patient at the time of the event, there was no adverse event reported.

• Brand Name: REUSABLE CLIP ADULT SPO2 SENSOR
• Common Device Name: REUSABLE CLIP ADULT SPO2 SENSOR
• 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: 23713034
• Report Number: 9610816-2025-001160
• Device Sequence Number: 8910804
• Product Code: DQA
• UDI-Device Identifier: 00884838001381
• UDI-Public: (01)00884838001381(10)IN62369657
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K062605
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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: REUSABLE CLIP ADULT SPO2 SENSOR
• Device Catalogue Number: 989803128631
• Device Lot Number: IN62369657
• 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: 11/06/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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