MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MICROSTREAM EXTENSION; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	INTELLIVUE MICROSTREAM EXTENSION
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed at a philips bench repair facility by a philips bench repair technician (brt).Diagnostic and functional testing confirmed the customer's reported malfunction when the device displayed 180mmhg while connected to a patient simulator set to 200mmhg.The brt indicated that this discrepancy was consistent with a faulty pressure board and/or connector block, so both parts were ordered with the plan to return any unused components.The evaluation concluded that the pressure board was defective and caused the inaccurate ibp readings the brt replaced the pressure board, after which the device produced accurate measurements.All required tests and verifications including co2 calibration and leakage testing were successfully completed.The connector board ultimately was not needed for repair and will be returned unused.All device functions were confirmed to be working correctly, and the unit is now fully functional and ready for use.The unit was returned to the customer.Based on the information available in the case and testing conducted, the cause of the reported problem was confirmed to be the pressure board.The alleged malfunction was confirmed.If additional information is received, the complaint file will be reopened for further investigation.
Event or Problem Description
The customer reported that the micro stream's ibp was not accurate as the device was giving measurements lower than normal.At 200/150 the unit gave a reading of 180/130.It is unknown if the device was in use at time of event, and there was no adverse event reported.

• Brand Name: INTELLIVUE MICROSTREAM EXTENSION
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• 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: 24696102
• Report Number: 9610816-2026-100596
• Device Sequence Number: 10109386
• Product Code: CCK
• UDI-Device Identifier: 00884838083585
• UDI-Public: (01)00884838083585
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172904
• 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): 03/26/2026

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 MICROSTREAM EXTENSION
• Device Catalogue Number: 867041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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