BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P-440 PORTABLE CEILING LIFT

    MDR report key: 9978061 · Received April 20, 2020

    Report

    Report Number
    3007802293-2020-00007
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    March 24, 2020
    Report Date
    October 15, 2020
    Manufacturer
    HANDICARE USA, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D1, D9, E, H6. MANUFACTURER NARRATIVE: THE UNIT WAS RETURNED AND CHARRING WAS NOTED ON THE PCB SURROUNDING THE MOUNTING HOLE. THE PCB MANUFACTURER INVESTIGATED THE UNIT AND STATES THE BURNING WAS MOST LIKELY CAUSED BY EXCESSIVE CURRENT FLOWING FROM THE CHASSIS CONNECTION AND THE BATTERY NEGATIVE CONNECTION THROUGH THE MOUNTING SCREW. THE SOURCE FOR THIS CURRENT COULD BE IF THE INSULATION ON THE BATTERY POSITIVE WIRE WERE COMPROMISED AND THE BATTERY POSITIVE WIRE MADE CONTACT WITH THE CHASSIS. THIS EVENT WOULD CREATE A SHORT CIRCUIT ON THE BATTERY CIRCUIT THAT WOULD BYPASS THE FUSE AND WOULD ULTIMATELY RESULT IN A FAILED CONDUCTOR TO TERMINATE THE PROCESS. THE PCB CIRCUITRY WAS MODIFIED IN (B)(6) 2019 TO AVOID THIS RESULT IF THE SITUATION WERE TO REOCCUR. THE RETURNED PCB WAS MANUFACTURED PRIOR TO THIS CHANGE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS REMOVED FROM SERVICE IMMEDIATELY AFTER THE EVENT AND IS BEING RETURNED TO THE MANUFACTURER FOR REVIEW.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT A P-440 CEILING LIFT BECAME HOT DURING USE AND EMITTED SMOKE FROM THE INTERNAL CIRCUIT BOARD. NO ONE WAS INJURED FROM THE EVENT. THE DEVICE WAS REMOVED FROM SERVICE AND IS BEING RETURNED TO HANDICARE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441924 P-440 PORTABLE CEILING LIFT P-440 FSA HANDICARE USA, INC. P-440

    Patients

    Seq Age Sex Outcome Treatment
    1