BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADS - PATIENT ALARM DISPOSABLE SYSTEM

    MDR report key: 3540145 · Received December 19, 2013

    Report

    Report Number
    MW5033608
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Report Date
    December 19, 2013
    Manufacturer
    MEDTEC MEDICAL, INC
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, 123 PADS BED/CHAIR ALARMS WERE INSTALLED IN PT CARE ROOMS. BY (B)(6) 2013, SIX MONITORS HAD BEEN REPORTED AS BROKEN/MALFUNCTIONING AND TAKEN OUT OF USE. THE JACK FOR THE NURSE AND PAD WERE NOT CONNECTING COMPLETELY CAUSING THE ALARMS TO NOT ALERT STAFF PROPERLY. REPRESENTATIVE NOTIFIED AND ALL 123 PADS ALARMS WERE REPLACED ON (B)(6) 2013. AT THE TIME OF REPLACEMENT, ONE ALARM WAS FOUND TO HAVE A DEFECTIVE CALL CORD JACK. THERE HAVE BEEN THREE ADD'L ALARMS REPORTED AFTER REPLACEMENT WITH THE FOLLOWING ISSUES: WHEN ALARM CONNECTED TO THE PAD THE MONITOR WAS HOT TO TOUCH, ALARM WOULD NOT RESET AFTER THE 30 SECOND DELAY AND WIRING PULLING OUT FROM THE BED PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664887 PADS - PATIENT ALARM DISPOSABLE SYSTEM PADS - PATIENT ALARM DISPOSABLE SYSTEM KMI MEDTEC MEDICAL, INC PADS-01
    664888 PADS - PATIENT ALARM DISPOSABLE SYSTEM PADS - PATIENT ALARM DISPOSABLE SYSTEM KMI MEDTEC MEDICAL, INC PADS - 01
    664889 PADS - PATIENT ALARM DISPOSABLE SYSTEM PADS - PATIENT ALARM DISPOSABLE SYSTEM KMI MEDTEC MEDICAL, INC PADS - 01
    664890 PADS - PATIENT ALARM DISPOSABLE SYSTEM PADS - PATIENT ALARM DISPOSABLE SYSTEM KMI MEDTEC MEDICAL, INC PADS - 01
    665285 PADS - PATIENT ALARM DISPOSABLE SYSTEM PADS - PATIENT ALARM DISPOSABLE SYSTEM KMI MEDTEC MEDICAL, INC PADS-01
    665286 PADS - PATIENT ALARM DISPOSABLE SYSTEM PADS - PATIENT ALARM DISPOSABLE SYSTEM KMI MEDTEC MEDICAL, INC PADS-01

    Patients

    Seq Age Sex Outcome Treatment
    1