BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRI FOWLER BACK STRETCHER

    MDR report key: 8261042 · Received January 18, 2019

    Report

    Report Number
    2431414-2016-00001
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Date of Event
    January 9, 2016
    Report Date
    January 25, 2016
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Product Code
    FPO
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BIODEX RECEIVED THE FDA MEDWATCH REPORT ON FEB. 29,2016. WE TRIED CONTACTING (B)(6), THE MANAGER OF PATIENT SAFETY, (B)(6) HOSPITAL - THE PERSON LISTED ON THE MEDWATCH FORM. WE TRIED EVERY 2 DAYS AND LEFT MESSAGES FOR HER. ON (B)(6), WE CALLED AND SPOKE TO (B)(6), MGR. OF CLINICAL ENGINEERING, TRYING TO GET INFORMATION ABOUT THE MRI STRETCHER AND WHAT THE PROBLEM WAS. (B)(6) DID NOT KNOW WHAT THE ISSUE WAS WITH THE TABLE AND HE SAID HE WOULD CONTACT (B)(6), WHO IS IN THE HOSPITAL, ABOUT THE FDA ISSUE AND PROBLEM WITH THE MRI STRETCHER. WE TRIED SEVERAL OTHER TIMES AND (B)(6) SAID SHE WOULD GET INFORMATION TO US, WHICH NEVER HAPPENED. ON 3/31/2016 WE TRIED (B)(6) AGAIN AND THEN CONTACTED (B)(6) AGAIN AND SPOKE TO HIM. HE HAD US TALK TO (B)(6), DIR OF PATIENT SAFETY. (B)(6) TOLD US THAT THE CASTER BENT AND THE TABLE FLIPPED AND HIT THE WALL. SHE DIDN'T KNOW HOW IT FLIPPED OR ANY DETAILED INFORMATION ABOUT THE CASTER ON THE TABLE. SHE DID NOT KNOW IF THEY DID ANY SERVICE TO IT OR PERIODICALLY CHECKED IT. SHE TOLD US SHE WOULD CHECK WITH ENGINEERING WHAT THEY DID. BIODEX CHECKED AND WE DO NOT HAVE A RECORD OF THEM ORDERING REPLACEMENT CASTERS IN THE LAST SIX (6) MONTHS. WE CALLED SEVERAL TIMES AND LEFT MESSAGES FOR (B)(6). ON 4/27/2016 WE CONTACTED (B)(6) AGAIN AND COPIED (B)(6) AS WE GOT AN EXPLANATION FROM (B)(6) THAT THE ROOT CAUSE OF THE PROBLEM WITH THE TABLE WAS A DAMAGED CASTER AND BEFORE THEY PUT THE MRI STRETCHER BACK INTO SERVICE, THE CASTER WAS REPLACED ON THE TABLE. WE ASKED IF THEY HAD CHECKED THE OTHER CASTERS, HOW THE TABLE WAS REPAIRED AND CERTAIN INFORMATION. (B)(6) FORWARDED THE INFORMATION TO THE DIR. OF FACILITIES ENGINEERING TO GET THE INFORMATION FROM THE EMPLOYEE WHO REPAIRED THE TABLE. WE WERE INFORMED THAT THE CASTER WAS BENT AND LOOSE AND THE TABLE FLIPPED AND HIT THE WALL. THE CASTER BEING LOOSE MEANS THE CASTER MAY NOT BE STRAIGHT. THEY HAVE NOW ADDED CHECKING THE TABLE INTO THEIR MAINTENANCE INSPECTION CHECK LIST IN THE FACILITY. THE INSTRUCTION MANUAL SAYS THEY SHOULD PERIODICALLY CHECK THE CASTERS THAT THEY ARE NOT LOSE AND ROLL PROPERLY. THEY HAD NEVER CHECKED TABLE IN THE SIX (6) YEARS THEY HAD THE TABLE. WE REQUESTED TO SEND A SERVICE REPRESENTATIVE TO INSPECT THE TABLE AND WE WERE FINALLY ABLE TO GET THE INFO FROM THE FACILITY. THE MRI STRETCHER WAS INSPECTED THE WEEK OF MAY 17, 2016 BY ONE OF OUR SERVICE REPRESENTATIVES. THE TABLE IS NOW FUNCTIONAL AND CORRECT. THE ISSUE WAS CAUSED BY THE FACILITY NOT PERFORMING THE WORK MAINTENANCE AND INSPECTIONS RECOMMENDED IN THE USER MANUAL.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: PT WAS ON MRI TABLE, BUT SCAN WAS ABORTED DUE TO PT MOVEMENT. PT WAS CONFUSED. MRI COMPATIBLE STRETCHER WAS USED TO TRANSFER PT FROM SCAN ROOM. MRI SAFE STRETCHER WAS PLACED AGAINST PT'S LOCKED BED AND LOCKED. MRI TECHNICIAN REMAINED AT HEAD OF MRI STRETCHER AND MONITOR TECHNICIAN WAS WALKING AROUND THE PT'S BED TO PREPARE TO MOVE PT, AND MRI STRETCHER "FLIPPED". THE PT FELL TO THE FLOOR BETWEEN THE MRI SAFE STRETCHER AND THE BED, ONTO HIS LEFT SIDE WITH HIS ARM CRADLING HIS HEAD. RAPID RESPONSE TEAM (RRT) WAS CALLED FOR ASSISTANCE. C-COLLAR WAS APPLIED BY RRT, AND THE PT WAS TAKEN TO CT FOR FURTHER ASSESMENT. WHAT WAS THE INTENDED ORIGINAL PROCEDURE? MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55214 MRI FOWLER BACK STRETCHER STRETCHER, WHEELED FPO BIODEX MEDICAL SYSTEMS, INC. 240-110

    Patients

    Seq Age Sex Outcome Treatment
    1 72.0 YR Required Intervention