BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA IGS 540

    MDR report key: 10552870 · Received September 18, 2020

    Report

    Report Number
    9611343-2020-00002
    Event Type
    Injury
    Date Received
    September 18, 2020
    Date of Event
    August 31, 2020
    Report Date
    October 23, 2020
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K181403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE INVESTIGATION ABOUT THIS EVENT HAS BEEN COMPLETED. THIS ISSUE OCCURRED ON (B)(6)2020 DURING THE REPLACEMENT OF THE LARGE DISPLAY MONITOR (LDM) POWER SUPPLY. IN ORDER TO COMPLETE THE LDM POWER SUPPLY REPLACEMENT, THE GEHC FIELD ENGINEER DETACHED THE 19¿? BACK-UP MONITOR ON THE BACK OF THE LDM; HOWEVER, THIS IS NOT PART OF THE SERVICE INSTRUCTIONS FOR POWER SUPPLY REPLACEMENT. WHEN THE REPLACEMENT WAS COMPLETED, THE FE WAS ATTEMPTING TO RE-ATTACH THE 19 MONITOR TO THE LDM RAIL. WHILE ALIGNING THE SCREW TO THE T-SLOT BOLT HE DROPPED THE SCREW. THE GEHC FE REACHED TO GRAB THE BOLT WHILE HIS LEFT HAND WAS SUPPORTING THE MONITOR WHICH SLIPPED OUT HITTING THE BRIDGE OF THE NOSE AND CAUSING A FRACTURE . ADEQUATE INSTRUCTIONS ARE PROVIDED IN SERVICE MANUAL REGARDING REPLACEMENT OF LDM POWER SUPPLY. IT IS CLEARLY STATED THAT THE POWER SUPPLY REPLACEMENT HAS TO BE DONE WITHOUT DETACHING THE 19¿? BACK-UP MONITOR. NEITHER DESIGN, ASSEMBLY NOR MANUFACTURE DEFECT, NOR FAILURE OR MALFUNCTION HAS BEEN IDENTIFIED. THIS IS AN ISOLATED CASE. THIS EVENT IS DUE TO A USER ERROR SINCE GEHC FIELD SERVICE ENGINEER REMOVED THE 19¿? MONITOR TO DO REPLACE THE LDM POWER SUPPLY, NOT FOLLOWING THE PROPER INSTRUCTIONS. THE GEHC FE WAS REMINDED ON(B)(6)2020 ABOUT THE CORRECT PROCEDURE TO REPLACE THE LDM POWER SUPPLY. BASED ON THIS ANALYSIS, NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510K WILL BE PROVIDED IN FOLLOW-UP REPORT. DATE OF DEVICE MANUFACTURE WILL BE PROVIDED IN FOLLOW-UP REPORT. GE'S HEALTHCARE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    ON (B)(6) 2020 DURING A SERVICE ACTIVITY, A GEHC FIELD SERVICE ENGINEER WAS ATTEMPTING TO RE-ATTACH A MONITOR TO THE SUSPENSION AND GOT INJURED. WHILE DOING THE REPARATION A BOLT FELL, THE FIELD ENGINEER TRIED TO REACH FOR THE BOLT WHILE HOLDING THE MONITOR WITH HIS LEFT HAND; THE MONITOR SLIPPED AND HIT THE BRIDGE OF THE NOSE AND CAUSED A FRACTURE. THERE IS NO GE DEVICE MALFUNCTION ASSOCIATED WITH THIS EVENT. MUST PROBABLE ROOT CAUSE IS RELATED TO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018373 INNOVA IGS 540 INNOVA IGS 540 OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other