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	Complete Blockage (1094)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the etco2 tubing required changing every 3-5 hours due to obstruction.This premature infant was on a humidified ventilator circuit in a humidified isolette and required co2 tubing changes every 3-5 hours.The tubing was integrated into the ventilator circuit between the ventilator and ballard suction.The clinical audit logs were reviewed by the remote service engineer, revealing co2 occlusion technical inop alarms at 12 hours and 10 hours.The tubing set up was reviewed, revealing no anomalies in the way the circuit was managed.The etco2 module was working fine for a few hours but then it would stop picking up the measurement, so the sensor was changed every 2-3 hours.It was noted there was no condensation in the tubing and no air leak.The customer could not determine what the cause of the issue was, though they suspected the module could be a cause.It was also clarified that breaking into the circuit multiple times to change out sensors is an infection risk and the nurse indicated '.This patient now has a positive trach aspirate and is sick'.The customer switched to transcutaneous measurement of co2 due to the reported issue.Further clarification was received that the infant patient presented with an infection following repeated sensor changes, which required antibiotics; however, the customer could not conclusively confirm the infection was due to the sensor changes.It was indicated the sensor changes were a risk factor.The baby remains in critical condition and has been transferred to the main nicu for a higher level of care, pending patient ductus arteriosus repair.The transfer to higher level of care was not related to the sensor issue.
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
A philips remote application specialist (rap) contacted the customer.The respiratory manager for that hospital unit indicated that they were going to work with the local medtronic representative for further clinical education.No further information was provided.Based on the information available, the cause of the reported problem was not determined.The reported problem was not confirmed but could not be ruled out.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Additional Manufacturer Narrative
Additional information has been received confirming that the customer was using a filterline (oridion microstream filterline h set with ref 006324) device; oridion is a company of medtronic.Photos indicate that in order to replace the filterline, the connection between the patients' tube and ventilator needs to be removed; therefore, neither the microstream extension performing the measurement nor other philips device caused or contributed to the obstruction of the filterline, which may have contributed to the alleged increased infection risk.Based on the information available, the cause of the reported problem was not caused by a failure to a philips device.If additional information is received, the complaint file will be reopened for further investigation.

• 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: 23609428
• Report Number: 9610816-2025-001096
• Device Sequence Number: 9978881
• Product Code: CCK
• UDI-Device Identifier: 00884838083585
• UDI-Public: (01)00884838083585
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2026

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: INTELLIVUE MICROSTREAM EXTENSION
• Device Catalogue Number: 867041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 04/02/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/23/2025; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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: Life Threatening; Required Intervention
• Patient Age: 1 DA
• Patient Sex: Unknown
• Patient Weight: 1 KG