BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED HOLDINGS LLC

    MDR report key: 15124509 · Received July 28, 2022

    Report

    Report Number
    1314417-2022-00018
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    June 30, 2022
    Report Date
    July 28, 2022
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE AS IT CAUSE DELAY IN THERAPY, THE PATIENT HAD TO BE RE-INTUBATED.

    Additional Manufacturer Narrative · 0

    REPORTABLE AS IT CAUSE DELAY IN THERAPY, THE PATIENT HAD TO BE RE-INTUBATED. COMPLAINT HISTORY REVIEWED. THERE HAVE BEEN 3 SIMILAR COMPLAINTS IN THE PREVIOUS 12 MONTHS. WITHOUT PICTURES OF FAILURE OR RETURNED PRODUCT, COMPLAINT CANNOT BE INVESTIGATED FURTHER. WHEN INVESTIGATING FOR (B)(4), IT WAS DETERMINED THAT COMPLAINT WAS CONFIRMED, AND PRODUCT HAD A DEFECT RATE OF 1/4360. SUPPLIER IS CHANGING RESIN BLEND OF HANDLE TO IMPROVE STRENGTH. SEE NCMR-02423/CC-07170 FOR MORE INFORMATION. RISK (RMA-20002B): R5: PLASTIC HEEL BREAKING - TORSION SHEAR OR TENSILE FORCES - S=7, O=2, RPN=14. RPN < 25 THEREFORE RISK IS ACCEPTABLE.

    Description of Event or Problem · 0

    BREAKING DURING INTUBATIONS. POTENTIALLY DELAYED INTUBATION.

    Description of Event or Problem · 0

    BREAKING DURING INTUBATIONS. POTENTIALLY DELAYED INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287449 SUNMED HOLDINGS LLC GREENLINE D F/O LED LARGE HANDLE CCW SUNMED HOLDINGS LLC 5-0236-69 221

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other