BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA Q

    MDR report key: 7429038 · Received April 13, 2018

    Report

    Report Number
    1017522-2018-00011
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Report Date
    March 16, 2018
    Manufacturer
    PELTON & CRANE
    Product Code
    FLE
    PMA / PMN Number
    K945117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZER WAS RETURNED TO PELTON & CRANE ON 3/28/2018. OUR EVALUATION INDICATES THERE WAS SEVERE DAMAGE TO THE FRONT OF THE STERILIZER INDICATING THE STERILIZER HAD FALLEN OFF THE TABLE IT WAS SITTING ON. MOREOVER, THE DOOR HANDLE BAR ASSEMBLY WAS BENT INWARDS INDICATING A DIRECT IMPACT TO THE FRONT OF THE STERILIZER WHEN THE STERILIZER FELL TO THE FLOOR. THE CHAMBER AND DOOR LOCKING MECHANISM WAS EVALUATED AND THERE WAS NO STRUCTURAL DAMAGE TO THE CHAMBER, DOOR, HINDGES, AND LATCHING PINS. PELTON & CRANE HAS LEFT MULTIPLE MESSAGES WITH THE DOCTORS OFFICE FOR DR. (B)(6) TO CALL US BACK TO FURTHER DISCUSS THE COMPLAINT HE E-MAILED TO US AS WELL AS TO DETERMINE THE DATE OF THE EVENT BUT THE DR. HAS NOT RETURNED OUR CALLS. AS A RESULT, THE STERILIZER APPEARS TO HAVE BEEN ABUSED AS IT WAS NOT PROPERLY POSITIONED ON THE TABLE FOR USE. ALSO THE STERILIZER WAS NOT BEING PROPERLY MAINTAINED OVER TIME AS THE STERILIZER CHAMBER, TRAYS, AND FILTERS ARE VERY DIRTY AND SHOWS LACK OF PROPER MAINTENANCE.

    Description of Event or Problem · 1

    PELTON & CRANE RECEIVED A COMPLAINT VIA E-MAIL STATING A DELTA Q 10" STERILIZER DOOR CAME OPEN DURING A STERILIZING CYCLE CAUSING A LOUD NOISE. THE STAFF WENT INTO THE ROOM AS SAW THE STERILIZER, TRAYS, AND THE VARIOUS INSTRUMENTS THEY WERE STERILIZING ON THE FLOOR WITH THE STERILIZER DOOR OPEN. NO ONE WAS IN THE ROOM WHEN THE EVENT TOOK PLACE. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270648 DELTA Q AUTOCLAVE FLE PELTON & CRANE AF

    Patients

    Seq Age Sex Outcome Treatment
    1