BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE CONSUMER P300 W/NON-CHARGING HAND CONTROL

    MDR report key: 5894941 · Received August 22, 2016

    Report

    Report Number
    3007802293-2016-00075
    Event Type
    Malfunction
    Date Received
    August 22, 2016
    Date of Event
    July 26, 2016
    Report Date
    September 15, 2016
    Manufacturer
    PRISM MEDICAL TORONTO LOCATION
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS P300 UNIT WAS RETURNED ON RGA 21802 AND EVALUATED BY PRISM MEDICAL ON AUG. 23, 2016. WHEN THE EMERGENCY DOWN (E-DOWN) AND HAND CONTROL'S UP, DOWN, AND E-DOWN WERE PRESSED THE UNIT DID NOT MOVE. THE UNIT CONTAINED AN OLDER MODEL PCB BOARD VERSION P300-RD. THE UNIT HAD A WORN STRAP, DAMAGE TO THE TOP COVER, DIFFERENT BATTERIES THAN THOSE INSTALLED, AND THE DRIVE GEAR EXTRUSION HAD BROKEN IN TORSION. THE FUNCTIONALITY OF THE OVERSPEED MECHANISM WAS UNABLE TO BE VERIFIED AND WAS NOT ENGAGED WHEN THE UNIT WAS OPENED. ROOT CAUSE: A MANUAL CHECK OF THE OVERSPEED ARM SHOWED IT MOVED SLOWER THEN INTENDED WITH NO EVIDENCE OF ENGAGEMENT. CORRECTION: THE LIFT WAS REPLACED WITH A REFURBISHED UNIT AT NO COST TO THE CUSTOMER. THE CUSTOMER HAD NOT PARTICIPATED IN THE 300 SERIES RECALL. CORRECTIVE ACTION: A PRODUCT RECALL WAS INITIATED FOR THE C/P 300 LIFT ON SEPTEMBER 8, 2015 UNDER THE FSN 0008. THE PURPOSE OF THE RECALL IS TO REPLACE THE DRIVE GEAR SHAFT AND OVER SPEED ARM/SHOULDER BOLT, BOTH WITH ENHANCED DESIGNS FOR C/P 300 UNITS DISTRIBUTED GLOBALLY BETWEEN FEB. 2012 - APRIL 1, 2015.

    Additional Manufacturer Narrative · 1

    OUTCOME OF INVESTIGATION PENDING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    THE CAREGIVER WAS IN THE PROCESS OF TRANSFERRING HIS WIFE/PATIENT FROM A CHAIR TO A BED USING A P300 LIFT, THE PATIENT FELL BACK INTO THE CHAIR .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545141 PORTABLE CONSUMER P300 W/NON-CHARGING HAND CONTROL P 300 FSA PRISM MEDICAL TORONTO LOCATION 303050

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR