BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPULSE ATP BED

    MDR report key: 1587211 · Received January 8, 2010

    Report

    Report Number
    1625774-2010-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2010
    Date of Event
    December 9, 2009
    Report Date
    December 9, 2009
    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 Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    KCI RECORDS INDICATE THAT THE THERAPULSE ATP BED WAS INITIALLY PLACED WITH THE ACCOUNT ON (B)(6)2009 AND REMAINED IN USE FOR APPROXIMATELY SEVEN DAYS. THE THERAPULSE ATP BED WAS RETURNED TO THE KCI SERVICE CENTER FOR EVALUATION. EVALUATION OF THE DEVICE REVEALED EVIDENCE THAT SCORCHING AND MELTING HAD OCCURRED WITH THE THERAPULSE ATP POWER CORD PLUG. ADDITIONALLY, THE THERAPULSE ATP POWER CORD WAS RETURNED TO THE KCI SERVICE CENTER WITH THE LINE IN PRONG MISSING. THE THERAPULSE ATP POWER CORD WAS REPORTED TO HAVE BEEN PLUGGED INTO A MULTIPLE OUTLET STRIP. THERAPULSE ATP LABELING STATES, AVOID FIRE HAZARDS - TO MINIMIZE RISK OF FIRE, CONNECT THE BED'S POWER CORD DIRECTLY INTO A WALL-MOUNTED OUTLET. DO NOT USE EXTENSION CORDS OR MULTIPLE OUTLET STRIPS. REVIEW AND FOLLOW FDA'S SAFETY TIPS FOR PREVENTING HOSPITAL BED FIRES (DATED DECEMBER 18, 2003) (B)(4).

    Description of Event or Problem · 1

    ON (B)(6)2009, IT WAS REPORTED THAT THE POWER CORD ON A THERAPULSE ATP BED SPARKED AND SMOKE WAS SEEN WHILE IT WAS PLUGGED INTO A MULTIPLE OUTLET STRIP AT THE HEALTHCARE FACILITY. NEITHER THE PATIENT NOR THE HEALTHCARE FACILITY STAFF WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPULSE ATP BED IOQ KCI USA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1