BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX LIFT

    MDR report key: 3070613 · Received April 12, 2013

    Report

    Report Number
    2183887-2013-00001
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    December 17, 2012
    Report Date
    April 12, 2013
    Manufacturer
    EZ WAY, INC.
    Product Code
    FNG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER DID NOT NOTIFY EZ WAY OF THE INCIDENT. EZ WAY RECEIVED COPY OF THE MDR SUBMITTED BY THE FACILITY FROM THE FDA. IN RESPONSE TO A NOTIFICATION ON (B)(4) 2005 BY THE OEM ACTUATOR MFR, SKF, THAT THESE ACTUATORS SHOULD BE REPLACED AFTER 4 YEARS, EZ WAY ISSUED THREE CONSECUTIVE LETTERS SENT (B)(4) 2005, (B)(4)2006 TO ALL CUSTOMER OWNING EZ LIFTS PREVIOUSLY MFG WITH THIS BRAND OF ACTUATOR STATING THE NEED TO REPLACE SKF ACTUATORS AFTER 4 YEARS, ALONG WITH A MAINTENANCE CHECKLIST SPECIFYING ACTUATOR MAINTENANCE GUIDELINES TO TAKE PLACE ON A MONTHLY BASIS. EZ WAY HAS NOT USED THIS ACTUATOR FOR PRODUCTION OR AS A REPLACEMENT PART SINCE (B)(4) 1999.

    Description of Event or Problem · 1

    DURING A TRANSFER, THE FLANGE ATTACHMENT FOR THE ACTUATOR'S OUTER TUBE CAME UNATTACHED FROM THE GAR BOX AT THE ATTACHMENT POINT CAUSING THE LEAD SCREW TO FALL. THE ACTUATOR INVOLVED WAS THE ORIGINAL ACTUATOR THAT WAS SOLD WITH THE MACHINE ON (B)(6) 1997. INAPPROPRIATE HANDLING OF THE ACTUATOR, ABNORMAL USE, AND LACK OF PROPER SERVICING OF THE ACTUATOR PRESENTS A RISK OF DAMAGE AND MATERIAL FATIGUE. THE ACTUATOR MFR, SKF/MAGNETIC CORPORATION, RECOMMENDS THAT ACTUATORS THAT HAVE BEEN IN SERVICE FOR MORE THAN FOUR YEARS BE REPLACED. THE ACTUATOR INVOLVED IN THE INCIDENT WAS THE ORIGINAL ACTUATOR SOLD WITH THE EZ LIFT IN 1997 AND HAD BEEN IN USE FOR 16 YEARS. EZ WAY PREVIOUSLY CONTACTED THE USER FACILITY THREE TIMES VIA LETTER AND SIX TIMES VIA PHONE STATING THE NEED TO REPLACE THEIR SKF ACTUATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157933 EX LIFT PATIENT LIFT FNG EZ WAY, INC. 796

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other