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

Model Number	REUSABLE ADULT SPO2 SENSOR
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on reusable adult spo2 sensor indicating that the spo2 measurement in incorrect at baseline.The device was in clinical use on a patient at the time of the event.No adverse event was reported.
Additional Manufacturer Narrative
Based on the results of the customer analysis, it was determined that the product has malfunctioned.The issue was resolved by replacing the sensor.

• Brand Name: SPO2 SENSOR
• 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: 25123594
• Report Number: 9610816-2026-100853
• Device Sequence Number: 21493176
• Product Code: DQA
• UDI-Device Identifier: 00884838010215
• UDI-Public: (01)00884838010215(10)1946G-76068
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: REUSABLE ADULT SPO2 SENSOR
• Device Catalogue Number: 989803144371
• Device Lot Number: 1946G-76068
• 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: 04/10/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2019
• 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