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

Model Number	REUSABLE CLIP ADULT SPO2 SENSOR
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips field service engineer (fse) tested the device functionality and found the spo2 sensor to be inoperable.A new spo2 sensor is needed; therefore, the fse provided the department with the information to order a new spo2 sensor.Based on the information available and the testing conducted, the cause of the reported problem was a faulty spo2 sensor.The reported problem was confirmed.The customer was provided information on ordering a replacement device to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
Philips received a complaint on a reusable clip adult spo2 sensor indicating the sensor is not working correctly; it is giving an inaccurate reading.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.

• Brand Name: REUSABLE CLIP ADULT 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: 23495983
• Report Number: 9610816-2025-001040
• Device Sequence Number: 18390493
• Product Code: DQA
• UDI-Device Identifier: 00884838001398
• UDI-Public: (01)00884838001398(10)10619
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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: M1196T
• Device Lot Number: 10619
• 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: 10/23/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2019
• 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