BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEREOS PET/CT

    MDR report key: 8020792 · Received October 30, 2018

    Report

    Report Number
    1525965-2018-00420
    Event Type
    Injury
    Date Received
    October 30, 2018
    Report Date
    October 11, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K123599
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    20-FEB-2019 (B)(6). THIS RECORD IS FOLLOW-UP 2 WITH THE FOLLOWING EDITS: TYPE OF REPORTABLE EVENT: SERIOUS INJURY. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.S

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT A PATIENT¿S HAND WAS PINCHED BETWEEN THE TABLE AND UPPER PALLET DURING AN EXAM. DURING THE EXAM, THE PATIENT PLACED HIS HAND ON THE EDGE OF THE TABLE AND AS THE TABLE MOVED INTO POSITION, THE PATIENT¿S HAND WAS PINCHED BETWEEN THE TABLE AND UPPER PALLET. THE PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THERE WAS NO SERIOUS INJURY; THIS WAS A PINCH ONLY. THE FSE EVALUATED THE SYSTEM AND CONFIRMED THAT THE SYSTEM IS COMPLIANT; THERE WAS NO SYSTEM MALFUNCTION. THE OPERATOR INSTRUCTED THE PATIENT NOT TO HOLD ONTO THE SIDE OF THE TABLE DURING THE SCAN. THE SYSTEM IS IN CLINICAL USE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    WE HAVE NOT COMPLETED OUR INVESTIGATION FOR THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. (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 CUSTOMER REPORTED THAT THE PATIENT PLACED THEIR HAND ON THE EDGE OF THE TABLE. PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE PATIENT'S HAND WAS PINCHED BETWEEN THE TABLE AND UPPER PALLET DURING A SCAN TOPOGRAPHIC EXAM. THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. THIS EVENT IS CURRENTLY UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861204 VEREOS PET/CT SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 882446

    Patients

    Seq Age Sex Outcome Treatment
    1