BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INX FOR INLINE

    MDR report key: 7004623 · Received November 6, 2017

    Report

    Report Number
    1523574-2017-00044
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    October 9, 2017
    Report Date
    January 15, 2018
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COT WAS EVALUATED BY AN AUTHORIZED FIELD TECHNICIAN AT THE COMPLAINANT'S SITE. A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED AND IT WAS DETERMINED THE SAFETY BAIL OF THE COT WAS FUNCTIONING ACCORDING TO SPECIFICATION AND WOULD CATCH THE FLOOR HOOK OF THE AMBULANCE AS INTENDED. IT WAS OBSERVED THE TELESCOPING HANDLE OF THE COT WAS BENT AS A RESULT OF THE INCIDENT. THIS HANDLE WAS REPAIRED AND THE COT WAS RETURNED TO SERVICE. THE REPORTED INCIDENT COULD NOT BE DUPLICATED. SUFFICIENT INSTRUCTIONS ARE CONTAINED IN THE IFU FOR THE REQUIRED ACTIONS AND PLACEMENT OF COT OPERATORS TO ENSURE A SAFE UNLOADING PROCESS OF THE COT DURING A PATIENT TRANSPORT. THERE HAVE BEEN NO ADDITIONAL REPORTS OF ALLEGED INJURY TO THE PATIENT. THE MEDIC WITH THE ALLEGED ARM INJURY WAS SEEN IN THE HOSPITAL FOR AN EXAM AND XRAY AND IT WAS REPORTED THE INJURY WAS A CONTUSION.

    Description of Event or Problem · 1

    COMPLAINANT IS ALLEGING THE SAFETY BAIL DID NOT CATCH THE HOOK AND THE STRETCHER LOWERED UNEXPECTEDLY WITH A PATIENT LOADED. THE PATIENT DID NOT SUSTAIN INJURIES, HOWEVER THE MEDIC ALLEGEDLY SUFFERED A MINOR ARM INJURY. THE MEDIC WAS EVALUATED IN THE EMERGENCY ROOM AND RELEASED. THE COMPLAINANT HAS REPORTED THEY HAVE NOT BEEN ABLE TO DUPLICATE THE ALLEGED ISSUE. THE COT WILL BE EVALUATED.

    Description of Event or Problem · 1

    COMPLAINANT IS ALLEGING THE SAFETY BAIL DID NOT CATCH THE HOOK AND THE STRETCHER LOWERED UNEXPECTEDLY WITH A PATIENT LOADED. THE PATIENT DID NOT SUSTAIN INJURIES; HOWEVER, THE MEDIC ALLEGEDLY SUFFERED A MINOR ARM INJURY. THE MEDIC WAS EVALUATED IN THE EMERGENCY ROOM AND RELEASED. THE COMPLAINANT HAS REPORTED THEY HAVE NOT BEEN ABLE TO DUPLICATE THE ALLEGED ISSUE. THE COT WILL BE EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784365 INX FOR INLINE INX FOR INLINE FPO FERNO-WASHINGTON, INC. 0015803

    Patients

    Seq Age Sex Outcome Treatment
    1 Other