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

Model Number	867041
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/01/2024
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
The customer reported that they were expecting to get a red alarm, but when patient spo2 fell below 88, which was the set limit, there was no yellow/red alarm reported.The patient was moved to another room due to this room failing to alarm when it should have.The device was in clinical use.The patient was near coding with severe desaturation.
Additional Manufacturer Narrative
The alarm log for bed 1024ucm was reviewed by a philips national support specialist (nss).Based on information provided by philips national service support (nss), the time and date for the issue being reported by the customer is 01aug2024 at 10:57:52; the patient was originally admitted to room 1024ucm and was transferred to room 1001ucm.The nss determined that there was no desaturation (desat) alarm on bed 1024ucm due to alarm configuration settings.The spo2 desat delay is configured to be 20 seconds with an spo2 desat set at 78 and the average time set at 16 seconds.Based on the information available and the testing conducted, the cause of the reported problem was configuration related.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.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
This report is a supplemental to correct the type of reported complaint.

• 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: 19974386
• Report Number: 9610816-2024-00511
• Device Sequence Number: 7048071
• Product Code: CCK
• UDI-Device Identifier: 00884838083585
• UDI-Public: (01)00884838083585
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2025

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: 867041
• Device Catalogue Number: 867041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 09/14/2024; 06/23/2025
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 08/15/2024; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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