BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOSCIENTIFIC FORMA STERICULT INCUBATOR

    MDR report key: 2702239 · Received August 9, 2012

    Report

    Report Number
    1523845-2012-00001
    Event Type
    Malfunction
    Date Received
    August 9, 2012
    Date of Event
    September 9, 2009
    Report Date
    July 27, 2012
    Manufacturer
    THERMOFISHER SCIENTIFIC (ASHEVILLE) LLC
    Product Code
    JTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION MADE IN 2008 FOR BROKEN HINGES THAT HAD NO INJURIES REPORTED, DROVE A PRODUCT IMPROVEMENT TO UPGRADE ALL UNITS WITH THE SUSPECT HINGE TO STRONGER STAINLESS STEEL HINGES. THIS CHANGE WAS IMPLEMENTED IN (B)(4) 2009, PRIOR TO THIS INCIDENT. IN ADDITION, A TECHNICAL SERVICE BULLETIN WAS ISSUED TO THE FIELD SERVICE STAFF IN (B)(4) 2009, AND UPDATED IN (B)(4) 2012, PROVIDING INSTRUCTIONS FOR REPLACEMENT OF ZINC HINGES TO STAINLESS STEEL. WORK TO CHARACTERIZE THE ROOT CAUSE OF THE FAILURE THROUGH BOTH INTERNAL AND EXTERNAL LAB ANALYSES HAVE PROVED INCONCLUSIVE, BUT IT IS BELIEVED TO BE RELATED TO UNDETERMINED AND UNDISCLOSED VARIATION IN THE PRODUCTION PROCESS OF THE HINGES BY THE HINGE MFR. NOTE: NO HINGE BREAKAGE REPORTS HAVE BEEN RECEIVED FOR UNITS WITH THE NEW STAINLESS STEEL HINGES.

    Description of Event or Problem · 1

    GENERAL PURPOSE INCUBATORS ARE CLASS I, 510 (K) EXEMPT, EXCEPT FOR (B)(4) (RECORDS) AND (B)(4) (COMPLAINTS). A COMPLAINT RELATED TO AN INJURY WAS RECEIVED ON (B)(4) 2009, ALLEGING THAT AN INCUBATOR'S OUTER DOOR SEPARATED FROM THE DEVICE DURING USE AND, WHILE OPENED, FELL AGAINST THE LAB TECH. THE COMPLAINT INDICATED THAT THE TECH HAD SOME PAIN AND SORENESS ON THE RIGHT SIDE OF THE USER'S FACE. BASED ON THIS INFO IN 2009, THERE WAS NO ALLEGATION OF SERIOUS INJURY. IN (B)(6) 2012, THE MFR WAS NOTIFIED OF A POTENTIAL CLAIM ARISING OUT OF THE 2009 INCIDENT. ON (B)(4) 2012, THE MFR RECEIVED MORE DETAILED INFO REGARDING THE CLAIM. SPECIFICALLY, THAT THE CLAIMANT HAD SUSTAINED A RIGHT SHOULDER INJURIES AND BRUISES WITH A "20% SCHEDULE LOSS OF USE OF RIGHT ARM" AS WELL AS SOME FACIAL BRUISING. THE EVENT WAS INITIALLY DESCRIBED BY THE END USER IN 2009: "YESTERDAY, AROUND 11:30 AM WHEN I WAS GOING TO PLACE SOME CELL LINES IN THE TOP INCUBATOR, THE INCUBATOR DOOR FELL ON MY FACE AT AN ANGLE AND THE CORNER OF IT LANDED ON MY EYE GLASSES. QUICKLY, I GOT HOLD OF THE DOOR WITH MY RIGHT HAND, SO IT WOULD NOT HAVE LANDED ON ONE OF MY FOOT, BUT I WAS STILL HOLDING THE CELL LINES (ABOUT 8 FLASKS) WITH MY LEFT HAND. I HAD TO EITHER RELEASE THE INCUBATOR DOOR OR THE FLASKS, BUT I LET GO OF THE INCUBATOR DOOR BECAUSE IT WAS GETTING TOO HEAVY. I TURNED AWAY FROM THE INCUBATOR AND TOOK A FEW STEPS TOWARDS THE ENTRANCE DOOR AND THEN I LET GO THE INCUBATOR DOOR. I WENT OCCUPATIONAL HEALTH AND SAFETY AND THEY RECOMMENDED THAT I GO TO THE HOSPITAL. BEFORE I WENT TO THE HOSPITAL, I NOTICED THAT THE INCUBATOR DOOR HAD BROKE OFF AT THE HINGES. I FEEL OK, BUT I FEEL PAIN AND SORENESS ON THE RIGHT SIDE OF MY FACE. I PLAN TO SEE A DOCTOR TODAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOSCIENTIFIC FORMA STERICULT INCUBATOR JTQ THERMOFISHER SCIENTIFIC (ASHEVILLE) LLC 3310

    Patients

    Seq Age Sex Outcome Treatment
    1 Other