BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER X1

    MDR report key: 10048655 · Received May 12, 2020

    Report

    Report Number
    1523574-2020-00014
    Event Type
    Injury
    Date Received
    May 12, 2020
    Date of Event
    May 3, 2020
    Report Date
    July 24, 2020
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    UDI-DI
    00190790002183
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE STRETCHER WAS RETURNED TO MANUFACTURER FOR EVALUATION. A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED AND IT WAS DISCOVERED AN IMPROPERLY INSTALLED STOW NET WAS INTERFERING WITH THE LOAD FRAME RELEASE BAR. THIS INTERFERENCE MAY HAVE NOT ALLOWED THE LOAD FRAME TO LOCK INTO POSITION WHICH WOULD CREATE IMPROPER WEIGHT DISTRIBUTION ON THE LOAD BEARING COMPONENTS AND COULD RESULT IN THE REPORTED ISSUE. THE STRETCHER WAS REPAIRED AND RETURNED TO THE CUSTOMER. THE IFU FOR THE STOW NET INCLUDES CLEAR INSTRUCTION ON PROPER INSTALLATION ON THE STRETCHER. NO ADDITIONAL INFORMATION WAS PROVIDED ON THE ALLEGED MEDIC INJURY.

    Description of Event or Problem · 0

    THE COMPLAINT ALLEGES WHILE UNLOADING A 430LB PATIENT FROM THE AMBULANCE, THE DROP FRAME ALLEGEDLY FAILED CAUSING THE WEIGHT OF THE STRETCHER TO SHIFT TOWARD THE OPERATORS. THE STRETCHER DID NOT FALL AND THE PATIENT WAS NOT INJURED; HOWEVER, A MEDIC IS ALLEGING A BACK AND KNEE INJURY, AS A RESULT. THE MEDIC WAS EVALUATED BY THE COMPANY'S CORPORATE HEALTH REPRESENTATIVE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THE COMPLAINT ALLEGES WHILE UNLOADING A (B)(6) PATIENT FROM THE AMBULANCE, THE DROP FRAME ALLEGEDLY FAILED CAUSING THE WEIGHT OF THE STRETCHER TO SHIFT TOWARD THE OPERATORS. THE STRETCHER DID NOT FALL AND THE PATIENT WAS NOT INJURED; HOWEVER, A MEDIC IS ALLEGING A BACK AND KNEE INJURY, AS A RESULT. THE MEDIC WAS EVALUATED BY THE COMPANY'S CORPORATE HEALTH REPRESENTATIVE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513736 POWER X1 POWER XI FPO FERNO-WASHINGTON, INC. 015807 00190790002183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other