BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENUITY TF PET/MR

    MDR report key: 10700380 · Received October 19, 2020

    Report

    Report Number
    3015777306-2020-00017
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Date of Event
    October 5, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OUO
    PMA / PMN Number
    K103483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE REPORTED WAS THAT PET/MR TABLE DID NOT STOP AT THE REQUESTED POSITION. THE SYSTEM WAS IN CLINICAL USE WHEN THIS EVENT OCCURRED. THERE WAS NO REPORT OF HARM. THE PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO EVALUATE AND CONFIRM THE REPORTED ISSUE. PER THE FSE, THE CUSTOMER USES A LIGHT-VISOR TO POSITION THE PATIENT IN THE BORE OF THE MR SCANNER. THE CUSTOMER DOES THIS POSITIONING BY USING A TUMBLE SWITCH TO MOVE THE PATIENT INSIDE THE BORE. NORMAL OPERATION IS THE TABLE STOPS AT THE POINT THE LIGHT-VISOR IS SET. HOWEVER, IN THIS EVENT, THE TABLE MOVED OVER THIS POINT. THE FSE CONFIRMED THAT WHEN THE CUSTOMER RELEASED THE TUMBLE SWITCH THE TABLE AUTOMATICALLY STOPPED. THE FSE REVIEWED LOGFILES AND DETERMINED THE HORIZONTAL ENCODER HAD FAILED. THE FAILED PART WAS REPLACED, AND THE TABLE WAS CALIBRATED TO RESOLVE THE ISSUE. THE SYSTEM WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE. PROBABLE CAUSE : FAULTY HORIZONTAL ENCODER. THIS EVENT IS NOT REPORTABLE. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED WAS THAT PET/MR TABLE DID NOT STOP AT THE REQUESTED POSITION. THE SYSTEM WAS IN CLINICAL USE WHEN THIS EVENT OCCURRED. THERE WAS NO REPORT OF HARM. BASED ON THE PROVIDED INFORMATION, THIS ISSUE HAS BEEN DETERMINED NOT TO BE A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020, (B)(6). NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED WAS THAT PET/MR TABLE DID NOT STOP AT THE REQUESTED POSITION. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161555 INGENUITY TF PET/MR TOMOGRAPHIC IMAGER COMBINING EMISSION CT WITH NULEAR MR OUO PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENUITY PET/MR

    Patients

    Seq Age Sex Outcome Treatment
    1