BEUDAMED
    FDA Adverse Event Injury Summary report: N

    91-SERIES

    MDR report key: 10447010 · Received August 25, 2020

    Report

    Report Number
    9616031-2020-00032
    Event Type
    Injury
    Date Received
    August 25, 2020
    Date of Event
    August 11, 2020
    Report Date
    October 9, 2020
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE STAFF MEMBER ATTENDED THE EMERGENCY DEPARTMENT AND WAS KEPT IN OVERNIGHT. SHE IS BEING TREATED BY HER DOCTOR AND IS CURRENTLY ON A SICK LEAVE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THERE IS A CORRECTION OF THE FIELD 'MANUFACTURE DATE' (H4) DUE TO THE REVIEW OF THE DOCUMENTS PROVIDED BY THE MANUFACTURING SITE: PREVIOUS DATE: 08/28/2014; CORRECTED DATE: 08/19/2014.

    Additional Manufacturer Narrative · 0

    FROM THE INFORMATION COLLECTED TO THE DATE, WE KNOW THAT THE GUIDE RAILS INTENDED TO GUIDE THE MOVEMENT OF CART WERE OUT OF ALIGNMENT. THE SAME ISSUE WAS DISCOVERED ON THE DEVICE BY THE GETINGE TECHNICIAN ON THE PREVIOUS VISIT. DURING THAT VISIT BEFORE THE EVENT, THE GETINGE TECHNICIAN CORRECTED THE RAIL AND INSTRUCTED THE STAFF MEMBER TO FOLLOW THE INSTRUCTIONS ABOUT INSTALLATION AND ALIGNMENT OF THE PART GIVEN IN THE INSTALLATION MANUAL OF THE DEVICE. HE ALSO SHOWED THE STAFF MEMBER HOW TO PROPERLY ADJUST THE PART. UNFORTUNATELY AFTER THE EVENT, THE SAME PART WAS FOUND REINSTALLED INCORRECTLY AND THE FACT WAS ESTABLISHED AS A ROOT CAUSE OF CART BLOCKING. IT WAS NOT ESTABLISHED WHO FROM THE FACILITY STAFF COULD PERFORM THE ALIGNMENT WORK ON THE DEVICE. THE FACT THAT CONTRIBUTED TO THE UNFORTUNATE ACCIDENT WAS CONCLUDED MOST LIKELY AS FACILITY TECHNICIAN ERROR. THE DEVICE DID NOT MEET ITS SPECIFICATION HOWEVER, IN THE TIME THE EVENT OCCURRED, IT WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS. AFTER THE EVENT OCCURRENCE, THE GETINGE TECHNICIAN ORGANIZED THE MEETING AND ONE MORE TIME INSTRUCTED ALL THE STAFF HOW TO HANDLE THE DEVICE PROPERLY. GIVEN THE FINDINGS OF THIS INVESTIGATION GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY OTHER ACTION RELATED TO THE DEVICE AT THIS TIME.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(6).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(6) .

    Additional Manufacturer Narrative · 1

    ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

    Description of Event or Problem · 1

    ON (B)(6) 2020 GETINGE BECAME AWARE OF AN ISSUE WITH 91-SERIES WASHER DISINFECTOR. AS IT WAS STATED, STAFF MEMBER HAD INJURED HERSELF WHILE REMOVING THE CART FROM WASHER AND SUSTAINED VERTEBRA T7 CRUSH FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911407 91-SERIES DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 9120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other