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

Model Number	INTELLIVUE BIS MODULE
Medical Device Problem Code	Low Readings (2460)
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
Philips received a complaint on the intellivue bis module indicating that the that the measured values were low.The device was in use on patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
E1: reporting institution phone# (b)(6).E1: reporter phone# (b)(6).A philips authorized service personal (asp) evaluated the device and could not replicate the reported issue.No error code was found; the device passed all functional tests.Visual inspection found no abnormalities.The customer confirmed they were no longer experiencing the problem.The equipment was operating normally and returned to use.There was no impact to the user or patient as no patient was involved.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.

• 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: 24929470
• Report Number: 9610816-2026-100737
• Device Sequence Number: 21500632
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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?: 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: 04/20/2026
• 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