MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MICROSTREAM EXTENSION

Model Number	INTELLIVUE MICROSTREAM EXTENSION
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis was performed by bench service personnel which included connecting the device to a host monitor without any issues.The device was unstable when connecting the hose to the microstream port.The co2 module was struggling to function.The bench repair technician replaced the co2 module and carried out verification tests.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.Section e reporting institution phone #: (b)(6).Section e reporter phone #: (b)(6).
Event or Problem Description
It was reported that on (b)(6) 2025, at 6 pm, the etco2 module stopped working during use, and it was indicated the interruption in monitoring resulted in severe harm.Another module was used to continue capnography along with a spot check monitor for spo2.There was no obvious damage to the device.No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.
Additional Manufacturer Narrative
Additional information received from a philips clinical engineer stated that the only alarms regarding etc02 that were noticed were: etco2 low, and co2 pump off with 2-3 minutes in-between each other.Further information was requested, regarding the reported severe harm, but no further information was able to be obtained from the customer.The device was returned to the philips repair bench.A bench repair technician (brt) tested the device.The unit connected to host monitor without any issues.The device was unstable when connecting the hose to microstream port.The module was struggling to function.The brt replaced the co2 module and carried out verification tests; the device passed testing.Based on the information available and the testing conducted, the cause of the reported problem was related to the hose connection to the mircostream port.The reported problem was confirmed.The device was operational after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MICROSTREAM EXTENSION
• Common Device Name: INTELLIVUE MICROSTREAM EXTENSION
• 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: 22233700
• Report Number: 9610816-2025-000497
• Device Sequence Number: 9068501
• Product Code: CCK
• UDI-Device Identifier: 00884838083585
• UDI-Public: (01)00884838083585
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2018
• 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
• Patient Sex: Unknown