BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PQ 5000

    MDR report key: 3202104 · Received June 19, 2013

    Report

    Report Number
    1525965-2013-00174
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Report Date
    May 24, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K943623
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, THE CUSTOMER, (B)(6) MEDICAL CENTER (B)(6), REPORTED THAT THE TABLE WENT OUT OF CALIBRATION DURING THE MIDDLE OF A LUNG BIOPSY. THERE WAS A NEEDLE IN THE PATIENT¿S LUNG WITHIN CLOSE PROXIMITY OF THE AORTA. THE TABLE JERKED OUT A GOOD 2 FEET AND IMMEDIATELY WENT BACK IN. THERE WAS NO BUG REPORT OR ERRORS IN ERROR LOG AT TIME OF INCIDENT. THE CUSTOMER DID NOT REQUEST ANY FURTHER SUPPORT OR SERVICE FROM PHILIPS. FURTHER INVESTIGATION BY ENGINEERING WAS UNABLE TO BE PERFORMED DUE TO UNAVAILABLE ERROR LOG/BUG REPORTS TO PERFORM FURTHER ANALYSIS. THE CUSTOMER HAS CHOSEN TO TAKE THIS SYSTEM OUT OF SERVICE AND HAVE IT REPLACED. SERVICE RECORDS INDICATED THAT THE SYSTEM MENTIONED IN THIS RECORD WAS REPLACED WITH AN INGENUITY FLEX IN (B)(6) 2014. TO ENSURE THIS WAS NOT A BROADER ISSUE CT ENGINEERING AND COMPLAINTS PERFORMED A HORIZONTAL ANALYSIS ON THIS ISSUE: THERE ARE TOTAL (B)(4) PQ5000 UNITS ARE IN USE WORLDWIDE AS OF (B)(4) 2015. THE COMPLAINT DATABASE SHOWED NO SIMILAR COMPLAINTS. ACCORDING TO CT ENGINEERING THE CT CHANGE REQUEST DATABASE SHOWED NO SIMILAR DEFECTS. CT ENGINEERING CONCLUDED THAT SINCE THERE WAS NO BUG REPORT OR ERRORS IN ERROR LOG AT TIME OF INCIDENT, AND THE CUSTOMER DID NOT REQUEST ANY FURTHER SUPPORT OR SERVICE FROM PHILIPS, FURTHER INVESTIGATION WAS UNABLE TO BE PERFORMED. THE CUSTOMER HAS CHOSEN TO TAKE THIS SYSTEM OUT OF SERVICE AND HAVE IT REPLACED. CT ENGINEERING DETERMINED THAT THE RISK WAS ACCEPTABLE FOR THIS ISSUE. THEREFORE IF IT WERE TO RECUR, IT WOULD NOT BE LIKELY TO CAUSE DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION FROM THE CUSTOMER THAT THE PATIENT SUPPORT TRAVELED OUT OF THE GANTRY 2 FEET WITHOUT COMMAND AND IMMEDIATELY WENT BACK IN THE GANTRY TO THE PREVIOUS POSITION WITHOUT COMMAND. THE PROCEDURE WAS HALTED AND THE PATIENT WAS MOVED TO A DIFFERENT CT SYSTEM TO COMPLETE THE PROCEDURE. PHILIPS SERVICE CONFIRMED THAT THERE WAS NO INJURY TO A PATIENT OR OPERATOR DUE TO THIS EVENT.

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION FROM THE CUSTOMER THAT THE PATIENT SUPPORT TRAVELED OUT OF THE GANTRY 2 FEET WITHOUT COMMAND AND IMMEDIATELY WENT BACK IN THE GANTRY TO THE PREVIOUS POSITION WITHOUT COMMAND. THE PROCEDURE WAS HALTED AND THE PATIENT WAS MOVED TO A DIFFERENT CT SYSTEM TO COMPLETE THE PROCEDURE. PHILIPS SERVICE CONFIRMED THAT THERE WAS NO INJURY TO A PATIENT OR OPERATOR DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279320 PQ 5000 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 72850

    Patients

    Seq Age Sex Outcome Treatment
    1