BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INX FOR INLINE WITH DWL

    MDR report key: 12071448 · Received June 25, 2021

    Report

    Report Number
    1523574-2021-00009
    Event Type
    Injury
    Date Received
    June 25, 2021
    Date of Event
    June 20, 2021
    Report Date
    July 1, 2021
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    UDI-DI
    00190790001339
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY AN AUTHORIZED SERVICE TECHNICIAN. THE TECHNICIAN FUNCTION, CYCLE AND WEIGHT TESTED THE UNIT AND FOUND NO DAMAGES AND/OR ISSUES THAT WOULD HAVE CONTRIBUTED TO THE SAFETY BAIL NOT ENGAGING WITH THE SAFETY HOOK. THE CAUSE OF THE INCIDENT WAS ATTRIBUTED TO THE OPERATORS INABILITY TO MAINTAIN CONTROL OF THE STRETCHER DURING THE OFF-LOADING OF THE STRETCHER FROM THE AMBULANCE. NO FURTHER DETAILS WERE PROVIDED PERTAINING TO THE ALLEGED INJURIES. THE DEVICE WAS CLEARED TO RETURN TO SERVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED WHILE UNLOADING THE STRETCHER FROM THE AMBULANCE, THE SAFETY BAIL DID NOT ENGAGE WITH THE SAFETY HOOK ALLEGEDLY ALLOWING THE COT TO ROLL OUT OF THE AMBULANCE STRIKING THE BUMPER OF THE AMBULANCE. AS A RESULT OF THE INCIDENT, THE PATIENT ALLEGED SUSTAINING A LACERATION ON HIS HEAD AND THE MEDIC SUSTAINED AN ALLEGED HAND INJURY WITH MEDICAL INTERVENTION CONSISTING OF AN ER EVALUATION AND GENERAL FIRST AID. THE COT WILL BE EVALUATED. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE UNLOADING THE STRETCHER FROM THE AMBULANCE, THE SAFETY BAIL DID NOT ENGAGE WITH THE SAFETY HOOK ALLEGEDLY ALLOWING THE COT TO ROLL OUT OF THE AMBULANCE STRIKING THE BUMPER OF THE AMBULANCE. AS A RESULT OF THE INCIDENT, THE PATIENT ALLEGED SUSTAINING A LACERATION ON HIS HEAD AND THE MEDIC SUSTAINED AN ALLEGED HAND INJURY WITH MEDICAL INTERVENTION CONSISTING OF AN ER EVALUATION AND GENERAL FIRST AID. THE COT WILL BE EVALUATED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961289 INX FOR INLINE WITH DWL INX FOR INLINE WITH DWL FPO FERNO-WASHINGTON, INC. 0015811 00190790001339

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other