BEUDAMED
    FDA Adverse Event Other Summary report: N

    KINAIR MEDSURG LOW AIR LOSS THERAPY

    MDR report key: 2974251 · Received February 14, 2013

    Report

    Report Number
    1625774-2013-00003
    Event Type
    Other
    Date Received
    February 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    ARJOHUNTLEIGH, INC.
    Product Code
    IOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED BY THE MFR ARJOHUNTLEIGH, INC. PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FROM THE MFG SITE KINETIC CONCEPTS INC. AS OF NOVEMBER 2012, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH INC. (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFRS INVESTIGATION.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO ARJOHUNTLEIGH BY THE ARJOHUNTLEIGH PRE: ON 02/01/2013, THE NURSE REPORTED THAT THE PT WAS FOUND ENTRAPPED ON THE PT LEFT SIDE OF THE BED. THE PT WAS IN ZONE 1, THE PT'S LOWER EXTREMITIES WERE ON THE FLOOR AND THE PT'S TORSO AND UPPER EXTREMITIES WERE WEDGED BETWEEN THE PT LEFT HEAD SIDE RAIL AND THE MATTRESS. THE PT LEFT HEAD SIDE RAIL WAS BENT BY THE NURSING STAFF IN ORDER TO FREE THE PT. THE PT SUSTAINED SEVERAL MINOR BRUISES TO THE TORSO AS A RESULT OF THE EVENT. THERE WAS NO OTHER HARM OR INJURY TO THE PT OR NURSING STAFF. IT WAS UNDETERMINED HOW THE PT BECAME ENTRAPPED. ON (B)(6) 2013, THE PT WAS DISCHARGED FROM THE HOSPITAL IN SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66345 KINAIR MEDSURG LOW AIR LOSS THERAPY IOQ ARJOHUNTLEIGH, INC. 201001W

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other