BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINAIR

    MDR report key: 1638158 · Received March 22, 2010

    Report

    Report Number
    1625774-2010-00025
    Event Type
    Malfunction
    Date Received
    March 22, 2010
    Date of Event
    February 20, 2010
    Report Date
    February 20, 2010
    Manufacturer
    KCI USA, INC.
    Product Code
    IOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE KINAIR MEDSURG PULSE WAS RETURNED TO THE KCI SERVICE CENTER AND EVALUATED BY THE SERVICE MANAGER. THE SERVICE MANAGER DETERMINED THAT THE LEFT FOOT SIDE RAIL LATCH WAS DAMAGED (BENT) WHICH PREVENTED THE SIDE RAIL FROM LOCKING IN THE "UP" POSITION. THE UNIT ((B)(4)) WAS TESTED PER QUALITY CONTROL PROCEDURES ON (B)(4) 2010 PRIOR TO PATIENT DELIVERY AND THE UNIT MET SPECIFICATIONS INCLUDING INSPECTION OF THE LATCH MECHANISM AND SIDE RAIL FUNCTIONALITY. SIDE RAIL FUNCTIONS WERE ALSO TESTED UPON DELIVERY ON (B)(4) 2010 AND MET SPECIFICATIONS. IT CANNOT BE DETERMINED WHEN THE LATCH WAS DAMAGED, BUT IT MOST LIKELY OCCURRED DURING USE AS THE UNIT MET SPECIFICATIONS UPON DELIVERY. KINAIR MEDSURG LABELING CAUTIONS "WHETHER AND HOW TO USE SIDE RAILS OR OTHER RESTRAINTS ARE DECISIONS THAT SHOULD BE BASED ON EACH PATIENT'S INDIVIDUAL NEEDS AND SHOULD BE MADE BY THE PATIENT AND THE PATIENT'S FAMILY, PHYSICIAN AND CAREGIVERS, WITH FACILITY PROTOCOLS IN MIND. CONSIDER NOT ONLY THE CLINICAL AND OTHER NEEDS OF THE PATIENT, BUT ALSO THE RISKS OF DEATH OR SERIOUS INJURY FROM FALLING OUT OF BED AND FROM PATIENT ENTRAPMENT IN OR AROUND THE SIDE RAILS, RESTRAINTS OR OTHER ACCESSORIES" AND TO "MONITOR RESTRAINED PATIENTS FREQUENTLY TO GUARD AGAINST PATIENT ENTRAPMENT AND MIGRATION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT FOOT SIDE RAIL WOULD NOT SECURE IN THE "UP" POSITION AND THE PATIENT ALLEGEDLY FELL OUT OF THE BED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINAIR IOQ KCI USA, INC. MEDSURG PULSE NA

    Patients

    Seq Age Sex Outcome Treatment
    1