MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH BIS MODULE; INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE

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	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the measurement values were low.The device was in use on a patient at the time of the event, there was no adverse event reported.
Additional Manufacturer Narrative
E1: reporter institution phone number: (b)(4).E1: reporter phone number: (b)(6).Reporting institution name (b)(6).Analysis was performed by a philips remote service engineer (rse) which included interviewing the customer and dispatching an authorized service provided (asp) onsite to further evaluate the unit.Once onsite, the asp tested the unit using the service manual but could not replicate the fault.The unit worked to specification.It could not be confirmed what may have been the root cause or what testing occurred.Based on the information available in the case, the cause of the reported problem was not confirmed.The alleged malfunction was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.If additional information is received, the complaint file will be reopened for further investigation.

• Brand Name: BIS MODULE
• Common Device Name: INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE
• 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: 24823714
• Report Number: 9610816-2026-100681
• Device Sequence Number: 9594548
• Product Code: OLW
• UDI-Device Identifier: 00884838051515
• UDI-Public: (01)00884838051515
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2025
• 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