BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEXX AMBULANCE COT

    MDR report key: 3925240 · Received June 23, 2014

    Report

    Report Number
    1523574-2014-00009
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    March 27, 2014
    Report Date
    June 12, 2014
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, IT WAS DETERMINED THAT THIS INCIDENT WAS NOT REPORTABLE DUE TO THE EVIDENCE, AT THE TIME, INDICATING THAT THE INCIDENT MAY HAVE OCCURRED DUE TO LACK OF CONTROL BY THE USER. AFTER CONTINUED COMMUNICATION WITH THE USER AND TECH, THE UNIT WAS RETURNED TO FERNO FOR EVAL ON (B)(4) 2014.

    Description of Event or Problem · 1

    FERNO WAS ADVISED ON (B)(6) 2014 FOR AN INCIDENT INVOLVING A TIP OVER OF A COT WITH A PT AS THE EMTS WERE UNLOADING THE UNIT. THE PT HAD A PRIOR EXISTING LEG INJURY BUT MAY HAVE INCURRED ADD'L INJURY DUE TO THE INCIDENT. AN EMT ALSO COMPLAINED OF LOWER BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365853 POWERFLEXX AMBULANCE COT POWERFLEXX AMBULANCE COT FPO FERNO-WASHINGTON, INC. 0015726

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization