MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH BIS MODULE; FULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPH

Model Number	862293
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: reporter institution phone number: (b)(6).E1: reporter phone number: (b)(6).Analysis was performed by a philips remote service engineer (rse) which included interviewing the customer and assisting with troubleshooting the unit.The troubled unit was replaced with another one onsite and the results showed the readings were better.It was confirmed the unit was not working and the readings were inaccurate.The rse provided the customer a replacement m_bis module bis, eng under contract to resolve the issue.Based on the information available in the case, the cause of the reported problem was confirmed to be the faulty bis module.The alleged malfunction was confirmed.If additional information is received, the complaint file will be reopened for further investigation.
Event or Problem Description
The customer reported that the unit was giving inaccurate reading.The device was in use on a patient at the time of the event, there was no adverse event reported.

• Brand Name: BIS MODULE
• Common Device Name: FULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPH
• 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: 24687220
• Report Number: 9610816-2026-100588
• Device Sequence Number: 9855137
• Product Code: GWQ
• UDI-Device Identifier: 00884838021105
• UDI-Public: (01)00884838021105
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/25/2026

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: 862293
• Device Catalogue Number: 862293
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2018
• 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