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

Model Number	REUSABLE ADULT SPO2 SENSOR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
Additional information was received which clarified there was no medical intervention and the redness faded quickly and completely.There was no known history of skin sensitivities or allergies in the patient's record.It was noted it was not likely there was residue from the disinfection process, the patient was not diaphoretic at the time of the event, and the spo2 sensor was not taped or clamped on the finger at the time of use.Based on this information, the reported redness on the patient's left hand was not life-threatening, did not result in permanent damage/impairment, and did not require medical intervention to preclude permanent damage/impairment; therefore, the event does not meet criteria for serious injury.Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Product return is pending.Additional product information was provided; therefore, the corresponding fields have been updated.
Event or Problem Description
Philips received a complaint on a reusable adult spo2 sensor indicating that the patient developed redness under the spo2 sensor.The patient complained of pain on the left hand where the spo2 sensor was placed.On the second and third fingers, redness and increased warmth were noted on the nail beds and knuckles.The spo2 sensor was then moved to second finger on the right hand but after approximately 10 minutes, redness appeared at the same location.After this time, monitoring was concluded as the patient was sent up to the ward.It was unclear whether this was a thermal injury or an allergic reaction.

• Brand Name: SPO2 SENSOR
• Common Device Name: 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: 24331623
• Report Number: 9610816-2026-100294
• Device Sequence Number: 14681112
• Product Code: DQA
• UDI-Device Identifier: 00884838010215
• UDI-Public: (01)00884838010215(10)2322G37606
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K062455
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: REUSABLE ADULT SPO2 SENSOR
• Device Catalogue Number: 989803144371
• Device Lot Number: 2322G37606
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown