BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IP5

    MDR report key: 24927871 · Received April 20, 2026

    Report

    Report Number
    MW5186983
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Report Date
    April 16, 2026
    Manufacturer
    INVIVO CORPORATION/PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OVER THE LAST 3 YEARS WE HAVE HAD CONTINUAL PROBLEMS WITH OUR PHILIPS MR 400 AND IP5 FOR MRI USE. LOOKING BACK AT THE CASE HISTORY, IN (B)(6) 2024, THIS ISSUE WAS FIRST REPORTED AND VERIFIED BY PHILIPS FSE AND SENT IN FOR EVALUATION (CASE# (B)(4)) WITH NO PROBLEM FOUND. THEN, IN (B)(6) 2025, A CASE WAS OPENED (CASE# (B)(4)) REGARDING A "SOFTWARE CONFIGURATION INVALID" MESSAGE. IT WAS RECOMMENDED BY PHILIPS TECH SUPPORT THAT THE SOFTWARE BE UPGRADED TO THE LATEST VERSION. WHEN THE FSE ARRIVED, HE FOUND THAT THE SOFTWARE WAS ALREADY AT THE LATEST VERSION WITH NO PROBLEM FOUND. IN (B)(6) 2025, THE SHUTTING DOWN ISSUE HAPPENS AGAIN (CASE# (B)(4)), AND THIS TIME PHILIPS TECH SUPPORT RECOMMENDS REPLACING THE DISPLAY ASSEMBLY. NOW IT IS SUGGESTED WE REPLACE THE MR400 PARAMETER PCBA. IF THE DISPLAY ASSEMBLY AND PARAMETER PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) ARE TRULY ISSUES, THEN WHY WASN'T THIS FOUND DURING THE EVALUATION OF THE DEVICE? PT CODE: 4582. DEVICE CODES: 1112, 4019. REF: MW5186982.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994387 IP5 MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI INVIVO CORPORATION/PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown