MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH MICROSTREAM CO2 EXTENSION; DETECTOR AND ALARM, ARRHYTHMIA

Model Number	862393
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported during an unknown event, the user was unable to calibrate the co2 device and readings could not be obtained, which was indicated by an inop alarm for 'equipment malfunction'.The module was taken to the biomed shop, where the same device behavior was noted.No other clinical information or medical intervention was reported.
Additional Manufacturer Narrative
A philips remote service engineer reached out to the customer to obtain information about the unknown event but was not provided any additional details.A philips bench repair technician (brt) evaluated the device and determined that it went end of life on december 31st, 2025.The parts required for repair are no longer supported.No pa performed, no tools used, defective sticker placed on device.The device was returned to the customer unrepaired and is not returned to functionality.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: MICROSTREAM CO2 EXTENSION
• Common Device Name: DETECTOR AND ALARM, ARRHYTHMIA
• 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: 24475095
• Report Number: 9610816-2026-100413
• Device Sequence Number: 13331493
• Product Code: DSI
• UDI-Device Identifier: 00884838021556
• UDI-Public: (01)00884838021556
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K993383
• 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,Followup
• Report Date (Section B): 04/16/2026

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: 862393
• Device Catalogue Number: 862393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2017
• 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: Required Intervention
• Patient Sex: Unknown