BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTOUCH

    MDR report key: 2915766 · Received December 7, 2012

    Report

    Report Number
    1831750-2012-12683
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS REPORTED BY THE SALES REP WHO HAS BEEN THE ONLY CONTACT. THE CUSTOMER DOES THEIR OWN MAINTENANCE AND DOES NOT WANT A FIELD TECH TO VISIT. THEY ARE ONLY REPORTING THIS TO BRING AWARENESS TO A POTENTIAL ISSUE FOR FUTURE DESIGN CONSIDERATION. THEY HAVE REMOVED THE O2 HOLDERS FROM ALL OF THE BEDS AND PURCHASED A DIFFERENT STYLE. THE SERIAL NUMBER OF THE BED WAS NOT KNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEADBOARD MOUNTED O2 TANK ALLEGEDLY FELL OFF AND HIT A PT IN THE HEAD DURING A PROCEDURE WHERE CLINICIANS WERE AT THE HEAD OF THE BED DURING A PROCEDURE. THE PT WAS FINE AND ONLY SUFFERED A MINOR ABRASION ON THEIR FOREHEAD AS A RESULT OF THE TANK AND BRACKET ALLEGEDLY FALLING OFF ONTO THEIR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTOUCH A/C HOSPITAL BED FNL STRYKER MEDICAL 2141 NA

    Patients

    Seq Age Sex Outcome Treatment
    1