BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDMARK

    MDR report key: 3815010 · Received April 25, 2014

    Report

    Report Number
    1523530-2014-00009
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MIDMARK CORP.
    Product Code
    NRU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE CHAIR WAS DONE ON-SITE AND AT OUR FACILITY. THE INVESTIGATION FOUND THAT THE ORIGINAL CHAIR BACK WAS REPLACED BY ANOTHER PARTY. WE WERE UNABLE TO LOCATE RECORDS FINDING WHO PERFORMED THIS REPAIR. THRU EVAL, WE HAVE CONFIRMED THAT EXISTING MOUNTING INSTRUCTIONS FOR REPLACING THE CHAIR BACK DO INCLUDE THE USE OF LOCTITE AND TORQUE SPECS FOR THESE BOLTS. WE WERE UNABLE TO DETERMINE IF THE TORQUE SPEC WAS EVER MET, BUT THERE WAS NO EVIDENCE OF LOCTITE USED. ABNORMAL WEAR MARKS SHOWING THE BOLT THREADS CUTTING INTO THE CASTING WAS NOTED ON THE LEFT SIDE OF THE CHAIR BACK MOUNTING. INVESTIGATIONS CONCLUDED THAT ONE BOLT HAD BACKED OUT PRIOR TO THIS FAILURE AND WAS NOT DETECTED FOR SOME TIME BASED ON THE APPEARANCE OF THE BOLT. SERVICING THAT WAS CONDUCTED BY A NON-MIDMARK ENTITY DID NOT FIND THIS FAILURE, ALTHOUGH THE CUSTOMER DID NOTE THAT THEY DETECTED SOMETHING "WRONG" WITH THE UNIT PRIOR TO FAILURE. AT THE TIME OF THIS REPORT, WE HAVE NOT BEEN ABLE TO ACQUIRE THE SERVICE RECORDS. THE INITIAL BOLT BACKING OUT OF THE CHAIR BACK CAUSED ADD'L DAMAGE TO THE CHAIR AND ULTIMATELY LEAD TO THE FAILURE OF THE SECOND MOUNTING POINT. THE FAILURE THAT OCCURRED HAS BEEN DETERMINED TO BE RELATED TO IMPROPER INSTALLATION AND SERVICING.

    Description of Event or Problem · 1

    THE UPPER PORTION OF CHAIR CAME APART WITH PT IN CHAIR. THE CHAIR TOP TIPPED ALLOWING THE PT TO FALL TO THE FLOOR. THE PT REPORTED STAINS FROM THE MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250476 MIDMARK CHAIR, DENTAL, WITHOUT OPERATIVE UNIT NRU MIDMARK CORP. 153592

    Patients

    Seq Age Sex Outcome Treatment
    1