BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SITTER SELECT ALARM

    MDR report key: 2232383 · Received August 26, 2011

    Report

    Report Number
    2020362-2011-00246
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED AN ALARM APPLICATION INSTRUCTIONS FOR USE AND ASKED IF THE ALARM HAS A DELAY FEATURE. CUSTOMER REPORTED THAT A PATIENT FELL WHILE THE ALARM WAS IN USE AND THAT IT TOOK A FEW SECONDS FOR THE ALARM TO SOUND. AFTER THE PATIENT FELL, THE CUSTOMER REMOVED THE ALARM AND SENSOR FROM USE. THE INITIAL REPORTER DID NOT KNOW THE PATIENT DETAILS; HE PROVIDED THE CONTACT INFORMATION FOR PATIENT DETAILS. THE REFERRED CONTACT WAS PHONED AND SHE STATED THE PATIENT WAS ADMITTED TO THEIR FACILITY ON (B)(6) 2011, FOR A PREVIOUS FALL, IN WHICH THE PATIENT HAD SUSTAINED A FRACTURE OF THE PUBIS PART AND HEAD LACERATION. ADDITIONALLY THAT ON (B)(6) 2011, THE PATIENT WAS SITTING IN A WHEELCHAIR AND FELL OUT OF IT. AFTER THE PATIENT FELL, X-RAYS WERE TAKEN THAT SHOW THE PATIENT SUSTAINED A NEW FRACTURE OF THE PUBIS, RIGHT CLAVICLE FRACTURE, AND A COMPRESSED FRACTURE OF THE TEETH SPINE. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THEIR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITTER SELECT ALARM KMI J. T. POSEY COMPANY 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other SINGLE PATIENT USE CHAIR PAD SENSOR: MODEL 8309| LOT # UNKNOWN