BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOVERMATT LATERAL PATIENT TRANSFER DEVICE

    MDR report key: 2159548 · Received July 5, 2011

    Report

    Report Number
    2531468-2011-00001
    Event Type
    Other
    Date Received
    July 5, 2011
    Date of Event
    May 16, 2011
    Report Date
    July 1, 2011
    Manufacturer
    D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INTERNATIONAL
    Product Code
    IKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, HOVERTECH (D.T. DAVIS ENTERPRISES, (B)(4)), RECEIVED AN E-MAIL FROM (B)(6), REPORTING AN INCIDENT WITH A HOVERMATT THAT OCCURRED ON (B)(6) 2011. THERE HAD BEEN NO PREVIOUS CONTACT MADE TO THIS ORGANIZATION REGARDING THIS INCIDENT. THE (B)(6) 2011 INCIDENT OCCURRED AT AN OFF-SITE FACILITY OF (B)(6). IMMEDIATELY AFTER RECEIVING THIS E-MAIL I CONTACTED (B)(6) TO OBTAIN THE HOSPITAL CONTACT INFORMATION AND ANY AVAILABLE UPDATES. ON (B)(4) AT 4:13 PM, I ALSO TRIED TO MAKE CONTACT WITH (B)(6). SHE WAS UNAVAILABLE AT THE TIME AND I LEFT A VOICE-MAIL MESSAGE REQUESTING HER TO CONTACT ME REGARDING THE REPORTED INCIDENT. I DID NOT RECEIVE A RETURN CALL FROM HER. I PHONED ON TWO OTHER OCCASIONS: (B)(4) 2011; BOTH TIMES LEAVING A CLEAR MESSAGE REGARDING THE REASON FOR MY CALL. SHE NEVER PHONED ME BACK. (B)(4) FOR D.T. DAVIS WAS ABLE TO REACH (B)(6) TO MAKE AN APPOINTMENT TO RE-TRAIN THE STAFF ON USING THE HOVERMATT AIR TRANSFER SYSTEM. RETRAINING WAS SCHEDULED FOR THE SECOND WEEK IN (B)(4) IN ORDER TO INCLUDE THE STAFF INVOLVED IN THE INCIDENT WHO AT THE TIME WERE ON VACATION. THE SALES DIRECTOR WAS ALSO ABLE TO OBTAIN (B)(6)'S E-MAIL ADDRESS. SHE DID NOT HOWEVER, PROVIDE ANY SPECIFIC INFORMATION REGARDING THE REPORTED INCIDENT. I SENT (B)(6) AN E-MAIL ON (B)(4) 2011, ASKING FOR AN UPDATE AND EXPLAINING THAT I WOULD NEED TO REPORT THIS INCIDENT TO THE FDA WITHIN 30 DAYS OF MY RECEIPT OF NOTIFICATION ON (B)(4) 2011. TO DATE I HAVE NOT RECEIVED ANY ADDITIONAL INFORMATION ABOUT THE INCIDENT. I WILL SEND AN UPDATED REPORT AFTER THE ON-SITE TRAININGS HAVE TAKEN PLACE.

    Description of Event or Problem · 1

    THE STAFF OVER-TRANSFERRED THE PATIENT FROM A CART OVER THE MRI TO THE FLOOR. THE PATIENT WAS UNHURT BUT A STAFF MEMBER MIGHT HAVE BEEN HURT. NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE FACILITY OR THE PRIOR ACCOUNT EXECUTIVE. D.T. DAVIS ENTERPRISES IS WORKING ON GETTING ADDITIONAL INFORMATION ABOUT THE INCIDENT. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. TO THE BEST OF MY KNOWLEDGE THE PRODUCT INVOLVED IN THE INCIDENT HAS NOT BEEN REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOVERMATT LATERAL PATIENT TRANSFER DEVICE DEVICE, PATIENT TRANSFER, POWERED IKX D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INTERNATIONAL UNKNOWN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN