MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH BIS MODULE; INTELLIVUE BIS MODULE

Model Number	INTELLIVUE BIS MODULE
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed a philips bench repair technician (brt) which included functional testing/verification using a patient simulator.The results of the analysis indicate the values were within acceptable parameters.The bis loc 4 cable was noted to be defective and the brt indicated it is possible the values are inaccurate after prolonged operation.Based on the results of the analysis, the product malfunction was unable to be confirmed; however, the bis loc 4 cable was noted to be defective, which may have contributed to the issue.The cable was replaced and, after repair, the device passed all functional testing.A review of the service history for this device shows the problem has not been reported again for this device.Based on the information available and results of additional analysis, no further action is necessary at this time.If additional information is received, the complaint file will be reopened for further investigation.
Event or Problem Description
Philips received a complaint on an intellivue bis module indicating that the displayed values do not correspond to the administered sedation.The device was in use on a patient at time of event, there was no adverse event reported.

• Brand Name: BIS MODULE
• Common Device Name: INTELLIVUE BIS MODULE
• 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: 24651120
• Report Number: 9610816-2026-100554
• Device Sequence Number: 9842252
• Product Code: OLW
• UDI-Device Identifier: 00884838051515
• UDI-Public: (01)00884838051515
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K003038
• 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): 03/20/2026

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 BIS MODULE
• Device Catalogue Number: 866421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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