BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED

    MDR report key: 20195814 · Received September 11, 2024

    Report

    Report Number
    1314417-2024-00027
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 23, 2024
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    CCW
    UDI-DI
    10889483008881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 11 SEPT 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 11 SEPT 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. PER WI-20020-C1 REV 2, SEC 15.6: FOR PRODUCTS IN WHICH AIRLIFE DISTRIBUTES, BUT IS NOT THE MANUFACTURER, COMPLAINTS WILL BE CAPTURED AND DISSEMINATED TO THE MANUFACTURER BUT DOES NOT REQUIRE INVESTIGATION, REPORTABILITY ASSESSMENT, CAPA ESCALATION, RISK ANALYSIS, AS THIS IS THE RESPONSIBILITY OF THE LEGAL MANUFACTURER AND WILL BE CLOSED

    Description of Event or Problem · 0

    LIGHT FLICKERS. WE HAVE BEEN HAVING PROBLEMS WITH FLICKERING IN OUR GREENLINE SUNBRITE LED HANDLES (5-0236-99 AND 5-0236-90). HAVE YOU HAD ANY OTHER COMPLAINTS? ONE OF THE DOCTORS SAID IF HE LOOSENS THE BULB IT DOESN'T FLICKER. IT'S LIKE THERE IS TOO MUCH DISTANCE BETWEEN THE BATTERY AND THE BULB. TYPICAL USE,

    Description of Event or Problem · 0

    LIGHT FLICKERS. WE HAVE BEEN HAVING PROBLEMS WITH FLICKERING IN OUR GREENLINE SUNBRITE LED HANDLES (5-0236-99 AND 5-0236-90). HAVE YOU HAD ANY OTHER COMPLAINTS? ONE OF THE DOCTORS SAID IF HE LOOSENS THE BULB IT DOESN'T FLICKER. IT'S LIKE THERE IS TOO MUCH DISTANCE BETWEEN THE BATTERY AND THE BULB. TYPICAL USE,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515848 SUNMED GREENLINE SUNBRITE LED PENLITE HANDLE CCW SUNMED HOLDINGS LLC 5-0236-90, 5-0236-99 UNKNOWN 10889483008881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other