BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST STEP

    MDR report key: 1660885 · Received April 14, 2010

    Report

    Report Number
    1625774-2010-00028
    Event Type
    Malfunction
    Date Received
    April 14, 2010
    Date of Event
    March 18, 2010
    Report Date
    March 18, 2010
    Manufacturer
    KCI USA, INC.
    Product Code
    IOQ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1625774-10/28/2009-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURES ON (B)(4) 2010, PRIOR TO DELIVERY TO THE ACCOUNT, AND MET SPECIFICATIONS. SUBSEQUENT TO THE REPORTED EVENT, THE FIRST STEP SELECT MATTRESS AND PUMP INCLUDING POWER CORD WERE RETURNED TO THE KCI SERVICE CENTER AND EVALUATED. EVALUATION OF THE POWER CORD CONFIRMED THAT THE NEUTRAL PRONG WAS DAMAGED AND REVEALED EVIDENCE THAT MELTING AND SCORCHING HAD OCCURRED. NO OTHER PROBLEMS WERE FOUND WITH THE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER CORD PLUG ALLEGEDLY MALFUNCTIONED WHILE AT THE HEALTHCARE FACILITY. THE FIRST STEP SELECT MATTRESS WAS INITIALLY PLACED WITH THE ACCOUNT ON (B)(4) 2010. THERE WAS NO REPORT OF AN INJURY TO THE PATIENT OR HEALTHCARE FACILITY STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST STEP IOQ KCI USA, INC. SELECT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA