BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINGFIELD ICU CRIB

    MDR report key: 2846958 · Received July 2, 2009

    Report

    Report Number
    1317511-2009-00001
    Event Type
    Injury
    Date Received
    July 2, 2009
    Date of Event
    June 29, 2009
    Report Date
    July 2, 2009
    Manufacturer
    HARD MFG. CO., INC.
    Product Code
    FMS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION OF CRIB: IMMEDIATELY MOVED CRIB FROM FLOOR TO CLINICAL ENGINEER. CHECKED INTEGRITY AND TIGHTNESS OF ALL HARDWARE AND FASTENERS, ALL OK. NO LOOSE, DAMAGED OR MISSING PARTS. NO DAMAGED OR DEFECTIVE SIDE RAILS OR FRAME ISSUES. CHECKED SIDE RAIL RELEASE FOR DEFECT AND PROPER FUNCTION. IT WAS FOUND IN UNIQUE CIRCUMSTANCES THAT IF THE RELEASE HANDLE WAS LET GO SLIGHTLY BELOW THE LOCKING HOLES THE ROD ENDS WOULD CATCH ENOUGH TO HOLD THE SIDE RAIL UP, WHICH WOULD THEN FALL TO THE NEXT LOWER POSITION WHEN WEIGHT WAS PUT ON IT. THIS WAS DIFFICULT TO REPEAT BECAUSE THE SIDE RAIL HAD TO BE IN JUST THE RIGHT POSITION, OTHERWISE IT WOULD EITHER LOCK AT THAT POSITION OR SLIDE DOWN AND LOCK AT THE NEXT LOWER POSITION. THE LAST PM INSPECTION OF THE CRIB WAS SEPTEMBER 2008. THE CRIBS ARE INSPECTED ONCE PER YEAR. INVESTIGATED WHETHER THERE WERE ANY RECALLS OR ECRI REPORTS CONCERNING THIS MODEL OF CRIB, NONE WERE FOUND. A REPRESENTATIVE CAME FROM HARD MANUFACTURING, (B)(4), WHO INSPECTED THE CRIB. (B)(4) FOUND NO DEFECTS OR MALFUNCTIONS WITH THE UNIT.

    Description of Event or Problem · 1

    (B)(4). (B)(6) 2009: (B)(6) PHONED TO REPORT A CHILD HAD FALLEN FROM A CRIB WITH THE PARENT'S IN THE ROOM. I ASKED IF THE CHILD WAS SERIOUSLY INJURED AND THE AGE. HE SAID THE CHILD WAS (B)(6) AND HAD SUFFERED A FRACTURED SKULL. HE ALSO INDICATED THE CHILD HAS BEEN TRANSFERRED TO ANOTHER FACILITY. I QUESTIONED THE MODEL AND YEAR OF THE PRODUCT HE SAID 943-CG MANUFACTURED IN 1988. I ADVISED HIM WE DID NOT SUPPORT PRODUCT FROM THAT YEAR. I QUESTIONED IF HE HAD TAKEN THE CRIB OUT OF SERVICE AND HE SAID YES. I TOLD HIM WE WOULD SEND OUR REP ((B)(4)) IN TO INSPECT THE CRIB AND REQUESTED AN INCIDENT REPORT. AS I WAS LOOKING IN THEIR ACCOUNT I NOTICED A 9 YEAR OR OLDER LETTER WAS SENT LAST YEAR TO (B)(6) ((B)(6) 2008). HE WAS AWARE OF THE LETTER. I INFORMED HIM THE DATA IN OUR COMPUTER WENT BACK TO 1993 AND I HAD NO RECORD OF THE PURCHASE. (B)(4) 2009: SPOKE TO (B)(6) TO DETERMINE IF (B)(4) HAD CONTACTED HIM AND REMIND HIM TO GET ME A COPY OF THE INCIDENT REPORT. HE SAID HE HAD COMPLETED THE REPORT IN DETAIL AND WAS WAITING FOR HIS BOSS TO REVIEW IT. (B)(4) 2009: CONTACTED HOSPITAL AND CONFIRMED (B)(4) HAD ARRIVED AT THE HOSPITAL. (B)(4) 2009: (B)(4) CONTACTED ME AND TOLD ME HE WOULD E-MAIL ME HIS REPORT TOMORROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINGFIELD ICU CRIB PEDIATRIC CRIB FMS HARD MFG. CO., INC. C943-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Hospitalization