BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM ADVANCED POWER LAMP HEAD AND POWER PACK

    MDR report key: 10901342 · Received November 25, 2020

    Report

    Report Number
    1000582314-2020-00004
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    October 30, 2020
    Report Date
    November 24, 2020
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON 10/30/2020 IN WHICH AFTER THE ISOLATION PROCEDURES AND PLACING THE LAMP NEAR THE PATIENT'S MOUTH, DENTAL ASSISTANT TURNED ON THE LAMP AND THE LAMP SPARKED. PATIENT FELT STING ON HER LEFT CLAVICLE AREA. THIS INCIDENT DID NOT CAUSE A DEATH, OR A SERIOUS INJURY. HOWEVER, SINCE THE PATIENT SOUGHT MEDICAL ATTENTION AND IN-OFFICE PROCEDURE USED ZOOM LAMP (CLASS I MEDICAL DEVICE), THIS INCIDENT WAS REPORTED TO FDA . ZOOM AP LAMP WITH SERIAL NUMBER (B)(4) WAS SHIPPED TO CUSTOMER ON 6/20/2007. ON 11/16/2020, WE RECEIVED THE ZOOM AP LAMP WITH SERIAL NUMBER (B)(4). RETURNED LAMP WAS EVALUATED AND FOUND THAT THE LAMP BUTTONS AND DISPLAY PANEL WERE FUNCTIONING. THE LAMP HAD 94 HOURS OF USAGE TIME. HOWEVER, THE LAMP WAS NOT EMITTING LIGHT. THE LIGHT BULB WAS BURNED OUT. NO FURTHER INFORMATION WAS PROVIDED ON THE PATIENTS WELLBEING AFTER SEVERAL ATTEMPTS BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, DISCUS DENTAL CONCLUDES THAT THE LAMP HAS BEEN IN USE FOR 13 YEARS. NO CORRECTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON 10/30/2020 IN WHICH AFTER THE ISOLATION PROCEDURES AND PLACING THE LAMP NEAR THE PATIENT'S MOUTH, DENTAL ASSISTANT TURNED ON THE LAMP AND THE LAMP SPARKED. PATIENT FELT STING ON HER LEFT CLAVICLE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366282 ZOOM ADVANCED POWER LAMP HEAD AND POWER PACK ZOOM CHAIRSIDE LAMP EEG DISCUS DENTAL, LLC ZM2613

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization