BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRIVE MEDICAL

    MDR report key: 2607580 · Received June 1, 2012

    Report

    Report Number
    3003910843-2012-00001
    Event Type
    Other
    Date Received
    June 1, 2012
    Date of Event
    March 22, 2012
    Report Date
    May 4, 2012
    Manufacturer
    SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY BASE ON THIS PARTIAL SERIAL NUMBER AND ITEM NO: (B)(4), WE DEDUCE THE RELATED CUSTOMER PURCHASE ORDER# SHOULD BE (B)(4) AND THIS BATCH SERIAL NUMBER FROM (B)(4) TO(B)(4). FROM THE PHOTOS PROVIDED BY (B)(4)'S INSURANCE COMPANY, WE BELIEVE THAT THIS ENTIRE BED OR AT LEAST THE HEADBOARD, FOOTBOARD AND BED RAILS DO NOT BELONG TO (B)(4). WE HAVE NEVER PRODUCED ANY SIMILAR COMPONENTS LIKE THESE. A LOGO IN THE LOWER LEFT CORNER OF FOOTBOARD DOES NOT BELONG TO (B)(4) OR (B)(4). WE HAVE REVIEWED ALL PAST COMPLAINTS AND NEVER FOUND ANY SIMILAR COMPLAINTS. WE HAVE REVIEWED THE FINAL QUALITY INSPECTION RECORD FOR CUSTOMER ORDER# (B)(4). ALL BEDS WERE MFG ACCORDING TO SPECS. NO POTENTIAL FIRE HAZARD HAS BEEN IDENTIFIED. WE HAVE REVIEWED ALL PROCESS INSPECTION RECORDS FOR CUSTOMER ORDER# (B)(4), ALL BEDS WERE MFG ACCORDING TO SPECS. NO POTENTIAL FIRER HAZARD HAS BEEN IDENTIFIED. THERE IS NO EVIDENCE AT THIS TIME INDICATING THAT THE ALLEGED DRIVE MEDICAL BED HAS IN ANY WAY CONTRIBUTED TO THE HOUSE FIRE. (B)(4) IS ACTIVELY COOPERATING WITH OUR DISTRIBUTOR IN THE US TO CONTINUE OUR INVESTIGATION ON THE INCIDENT. UNIDENTIFIED BED ENDS MADE BY UNK MFR WERE INSTALLED WITH THE DRIVE MEDICAL BED. THE PHOTOS FROM THE INSURANCE COMPANY INDICATE THAT THE ALLEGED HOMECARE BED WAS INSTALLED WITH A COMBINATION OF DRIVE MEDICAL COMPONENTS FROM OTHER MFRS. AT LEAST THE HEADBOARD, FOOTBOARD AND BED RAILS DO NOT BELONG TO SHANGHAI SHUNLONG. THE EFFECTIVENESS AND SAFETY OF COMBINATION OF THE PRODUCTS CANNOT BE VERIFIED AT THIS TIME. (B)(4), OUR DISTRIBUTOR IN THE US, IS IN THE PROCESS OF IDENTIFYING THE RESPONSIBLE PARTY WHO ORIGINALLY INSTALLED THE ALLEGED BED AT THE PT'S HOME.

    Description of Event or Problem · 1

    ONE OF OUR DISTRIBUTORS IN THE US, (B)(4), HAS RECEIVED A PROPERTY DAMAGE CLAIM FROM THEIR CUSTOMER'S INSURANCE COMPANY ABOUT A HOUSE FIRE. IT IS ALLEGED THAT THE FIRE ORIGINATED AT OR NEAR A HOMECARE BED MFG BY (B)(4). WE ARE CURRENTLY COOPERATING WITH THE INSURANCE CO AND (B)(6) FIRE MARSHALL THROUGH DRIVE MEDICAL IN INVESTIGATING THE INCIDENT. THIS MDR REPORT IS BASED ON THE MDR REPORT SUBMITTED BY DRIVE MEDICAL AND ADD'L INFO PROVIDED BY THIS DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL HOMECARE BED FNL SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA