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

Model Number	862293
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer biomed who stated when testing the bis engine, the signal quality indes (sqi) value is low, stays at 0.The biomed also stated that they have checked the patient and module interface cables, and still having the same problem.The sensor impedance was also checked and they are ok.The rse determined that the device would need to be replaced.The customer was provided a quote for a replacement device, waiting customer response to the quote.A follow up report will be submitted once the investigation is complete.Reporting institution phone#: (b)(6).
Event or Problem Description
It was reported that the signal quality indes (sqi) value is low, stays at 0.The device was not in use on a patient at the time of the event.There was no adverse event reported.
Additional Manufacturer Narrative
The customer was provided a quote for a replacement device but has not responded to the quote and the quote has expired.It is unknown how the issue was resolved for 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.

• Brand Name: PHILIPS 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: 24037179
• Report Number: 9610816-2026-100064
• Device Sequence Number: 10498400
• 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,Followup
• Report Date (Section B): 01/28/2026

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: Other
• Device Model Number: 862293
• Device Catalogue Number: M1034A
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/17/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2020
• 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