BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTOPRONE THERAPY (SYSTEM)

    MDR report key: 1884125 · Received October 21, 2010

    Report

    Report Number
    1625774-2010-00098
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    KCI USA, INC.
    Product Code
    IKZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BED WAS TESTED PER QUALITY CONTROL PROCEDURES ON (B)(6) 2010 AND MET SPECIFICATIONS PRIOR TO PATIENT PLACEMENT ON (B)(6) 2010. IT WAS IDENTIFIED THAT THERE WERE NO PACKS MISSING BUT RATHER THE GRAY SLIDES ON THE TOP OF THE PACK WERE MISSING. THIS IS WHERE THE ABDOMINAL SLING PACKS ARE USED FOR ATTACHMENT. A SERVICE ASSOCIATE PROMPTLY DELIVERED THREE REPLACEMENT ROTOPRONE PACKS WITH CLIPS ON THEM AND PICKED UP THE PACKS THAT WERE ON THE BED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE NURSE REPORTED VIA TELEPHONE THAT THE ROTOPRONE BED WAS MISSING THE ABDOMINAL CLIPS. ON 28 SEP 2010, THE NURSE WHO REPORTED THAT WHEN THEY PLACED THE PATIENT ON THE BED, IT WAS IDENTIFIED THAT SOME PIECES WERE MISSING AND THE PATIENT COULD NOT BE MECHANICALLY PRONED USING THE BED. IT WAS ALSO REPORTED THAT THE PATIENT'S O2 SATURATION WAS DECLINING. ON 29 SEP 2010, THE INTENSIVE CARE UNIT MANAGER WHO REPORTED THAT THE MISSING PIECES INCLUDED THE PART THAT HOLDS THE ABDOMINAL BINDER. THE MANAGER SPOKE WITH A KCI REPRESENTATIVE WHO INFORMED HER THAT SHE COULD STILL PRONE THE PATIENT WITHOUT THE MISSING PARTS. THE PATIENT'S O2 SATURATIONS BY THIS TIME CONTINUED TO DECLINE. THE NURSE PRONED THE PATIENT AS DIRECTED BY THE KCI REPRESENTATIVE AND AFTER BEING PRONED FOR APPROXIMATELY 3 HOURS, THE PATIENT'S O2 SATURATION WENT UP TO 125%. IT WAS LAST REPORTED THAT THE PATIENT WAS DOING BETTER AND WAS ABLE TO SPEND SEVERAL HOURS IN THE SUPINE POSITION. THIS IS BEING REPORTED AS THE DELAY IN THERAPY MAY HAVE CONTRIBUTED TO THE DECLINING O2 SATURATION LEVELS. AS OF THE DATE OF THIS REPORT, THERE WAS NO INDICATION OF ANY PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTOPRONE THERAPY (SYSTEM) IKZ KCI USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other REGULAR INSULIN DRIP| CARDIZEM| FENTANYL DRIP| VERSED DRIP| TOTAL PARENTERAL NUTRITION| ZIMURON DRIP