MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5

Model Number	INTELLIVUE MP5
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The philips remote service engineer (rse) interviewed the customer and advised them this was a sign of a defective spo2.The spo2 was attached to the other measurement boards.The entire pca board needed to be replaced.There appeared to be no other damage to the unit.Diagnostic/functional testing was performed at the philips repair facility.Results of the evaluation confirmed the customer's alleged malfunction.The philips bench repair technician (brt) installed a new pca board to resolve the issue.The unit has returned to working specification.Based on the information available and the testing conducted, the cause of the reported problem was confirmed to be the spo2 pca board.The reported problem was confirmed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
The customer states that the spo2 is not working and it is giving incorrect readings.The device was in use on a patient at the time of the event, there was no adverse event reported.

• Brand Name: INTELLIVUE MP5
• Common Device Name: INTELLIVUE MP5
• 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: 24118057
• Report Number: 9610816-2026-100108
• Device Sequence Number: 18564295
• Product Code: MHX
• UDI-Device Identifier: 00884838000230
• UDI-Public: (01)00884838000230
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K150310
• 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): 01/20/2026

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: INTELLIVUE MP5
• Device Catalogue Number: 865024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2020
• 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