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

Model Number	INTELLIVUE MICROSTREAM EXTENSION
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1; reporter institution phone number (b)(6).E1: reporter phone number (b)(6).The remote service engineer (rse) noticed that there were several loose parts that needs to be fixed.The rse requested the device to be sent to bench for further repair.Diagnostic/functional testing was performed at the philips authorized repair facility.Results of functional testing indicated that the board was defective and had a loose part.The parameter board was replaced.Based on the information available and the testing conducted, the cause of the reported problem was a faulty parameter board.The reported problem was confirmed.The parts were replaced at the bench.The device was operational after repairs were completed and the device was returned to the customer.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
Philips received a complaint on the intellivue microstream extension indicating that alarms for technical error measurement is absent.The device was in clinical use at time of event, no patient or user harm was reported.

• 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: 23028407
• Report Number: 9610816-2025-000833
• Device Sequence Number: 9427910
• Product Code: CCK
• UDI-Device Identifier: 00884838083585
• UDI-Public: (01)00884838083585
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 09/11/2025

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: 09/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2019
• 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