BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATALYST NON-EXPANDABLE BED

    MDR report key: 14326510 · Received May 7, 2022

    Report

    Report Number
    3005179379-2022-00005
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    April 21, 2022
    Report Date
    May 6, 2022
    Manufacturer
    KREG MEDICAL, INC
    Product Code
    FNL
    UDI-DI
    00850520008143
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022 AT APPROXIMATELY 5:20 PM, KREG'S SALES REPRESENTATIVE CONTACTED THE FACILITY'S DIRECTOR OF SAFETY, AND HE PROVIDED ADDITIONAL DETAILS. AN RN AND PATIENT TECHNICIAN WERE TRANSPORTING A PATIENT TO DIALYSIS 3RD FLOOR, NORTH BUILDING. THE PATIENT TECHNICIAN WAS PULLING THE BED WITH HER HANDS ON THE FOOTBOARD. THE RN WAS PUSHING THE BED AND AN IV POLE STAND WHEN THE INCIDENT OCCURRED. ON (B)(6) 2022 KREG'S SALES REPRESENTATIVE INSPECTED THE BED AFTER PATIENT USE ON-SITE BEFORE REMOVING IT FROM THE FACILITY AND FOUND THE BED FUNCTIONS TO BE WORKING AS INTENDED ALONG WITH THE BED REFERENCE GUIDE ATTACHED TO THE BED. HE INSPECTED THE BED STEERING AND BRAKE FUNCTIONS OF THE BED AND TOOK PICTURES AND VIDEOS TO CONFIRM THEIR FUNCTIONALITY. LATER THAT DAY ON (B)(6) 2022, THE FACILITY EQD MANAGER HAD THE FACILITY'S BED REPAIR TEAM EVALUATE THE KREG BED. THE FACILITY BED REPAIR TEAM DETERMINED AND COMMUNICATED TO THE KREG'S SALES REPRESENTATIVE THAT THE BED FUNCTIONS WERE WITHOUT ANY ISSUES. STEER, NEUTRAL, AND THE BRAKES WERE DEMONSTRATED AMONG OTHER FUNCTIONS TO BE WORKING AS INTENDED. ON (B)(6) 2022 AT 11:16 AM, THE BED WAS REMOVED FROM THE FACILITY AND BROUGHT BACK TO THE DISTRIBUTION CENTER FOR PROCESSING, THE BED WAS EVALUATED BY KREG MAINTENANCE TECHNICIAN AN 80-POINT INSPECTION WAS CONDUCTED ON THE PRODUCT WITH NO ELECTRICAL OR MECHANICAL FINDINGS. RECORD# (B)(4). ON (B)(6) 2022 AT 11:30 AM, KREG'S SALES REPRESENTATIVE ALONG WITH KREG'S DIRECTOR OF SALES VISITED THE SCENE AND FOUND THAT IT WAS UNDER CONSTRUCTION AT THE TIME OF THE EVENT AND THAT THE HALLWAY WIDTH HAD BEEN NARROWED BY A PROVISIONAL WALL THAT PROTRUDED INTO THE HALLWAY. AS OF THE DATE OF THIS DOCUMENT, THE FACILITY HAS NOT YET RELEASED ITS INTERNAL REPORT OF THIS INCIDENT TO KREG. IF KREG RECEIVES FURTHER INFORMATION A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2022 AT APPROXIMATELY 5:00 PM, IT WAS REPORTED DIRECTLY TO KREG SALES REPRESENTATIVE VIA A PHONE CALL FROM THE FACILITY NURSE MANAGER THAT AN INCIDENT HAD OCCURRED WITH ONE OF THE KREG BEDS. THE NURSE MANAGER PROVIDED A BASIC INITIAL VERBAL STATEMENT OF THE INCIDENT. SHE REPORTED THAT A NURSE TECHNICIAN HAD A FINGER AMPUTATED AFTER AN INCIDENT RELATED TO HER INVOLVEMENT IN TRANSPORTING A PATIENT ON A KREG BED TO DIALYSIS. THE INITIAL REPORT STATED THE PATIENT CARE TECHNICIAN WAS PULLING THE BED AND A NURSE WAS PUSHING THE BED WHEN IT HIT A BOX ATTACHED TO THE WALL, NO FURTHER DETAILS WERE PROVIDED AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804366 CATALYST NON-EXPANDABLE BED CATALYST NON-EXPANDABLE BED FNL KREG MEDICAL, INC ASM100113 4 00850520008143

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| O