BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-WIDER BARIATRIC BED

    MDR report key: 7347094 · Received March 16, 2018

    Report

    Report Number
    3005179379-2016-00003
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    December 27, 2015
    Report Date
    January 25, 2015
    Manufacturer
    KREG MEDICAL INC
    Product Code
    OSI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3005179379-2016-00003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT IS LATE DUE TO THE FIRM'S TECHNICAL PROBLEM WHICH HAS RECENTLY BEEN RESOLVED. A CAPA WAS INITIATED TO CORRECT TECHNICAL PROBLEM, ORIGINAL SUBMISSION PROVIDED AN ACKNOWLEDGEMENT RECEIPT. DISCOVERY OF THE TECHNICAL ISSUE WAS FOUND DURING THE FIRM'S RECENT INSPECTION BY FDA ON 01/23/2018. KREG MEDICAL HAS WORKED WITH CDRH AND ESG GATEWAY HELP DESK TO RESOLVED ISSUE ALONG WITH INITIATING A CAPA #(B)(4) TO PREVENT REOCCURRENCE.

    Description of Event or Problem · 1

    REPORT: KREG RECEIVED A REPORT ON (B)(6) 2015 THAT THE CASTERS ON ONE SIDE OF AN EZ WIDER BARIATRIC BED ROSE OFF THE FLOOR WHILE ONE NURSE AND ONE CARE PARTNER TURNED A PATIENT LATERALLY IN ORDER TO PERFORM A BEDPAN PROCEDURE. THE BRAKES WERE REPORTEDLY ENGAGED DURING THIS INCIDENT WITH THE BED HEIGHT POSITIONED TO THE WAIST LEVEL OF THE NURSE. IT WAS REPORTED THAT BOTH SIDE RAILS ON THE SIDE THE PATIENT WAS TURNING TO WERE IN THE FULL UP POSITION DURING THIS EVENT. THE PATIENT WAS REPORTEDLY POSITIONED ON HER SIDE, AGAINST THE SIDE RAILS WITH A PORTION OF HER BODY HANGING OUTSIDE OF THE BED PERIMETER. A WOODEN ARM REST OF A BARIATRIC CHAIR IN THE ROOM WAS DAMAGED DURING THIS INCIDENT. THE PATIENT RESTRAINT HOLDER ON THE BOTTOM OF THE FOOT DECK AND THE PATIENT DRAINAGE BAG HOLDER UNDER THE SEAT DECK WERE DAMAGED. THE DAMAGED RESTRAINT HOLDER AND DRAINAGE BAG HOLDER WERE LOCATED ON THE PATIENT LEFT SIDE OF THE BED. THE OPPOSITE SIDE OF THE BED THAT THE PATIENT WAS TURNING TO. THE PATIENT WAS ALSO REPORTED TO BE POSITIONED LOW IN THE BED (TOWARD THE FOOT END OF THE PATIENT PLATFORM) WHEN THIS EVENT TOOK PLACE. THE PATIENT WEIGHED (B)(6) AND WAS NOT INJURED. INITIALLY ONE INJURY TO THE CARE PARTNER WAS REPORTED. HE WAS SENT FOR AN MRI BUT DID NOT REQUIRED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187337 EZ-WIDER BARIATRIC BED EZ-WIDER BARIATRIC BED OSI KREG MEDICAL INC ASM100104 17

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization