BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGRATH MAC

    MDR report key: 19706920 · Received July 9, 2024

    Report

    Report Number
    3010244187-2024-00012
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    December 26, 2022
    Report Date
    August 14, 2024
    Manufacturer
    AIRCRAFT MEDICAL LIMITED
    Product Code
    CCW
    UDI-DI
    15060272980020
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2936999-07-22-2024-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H7, H9 (ASSOCIATED RES NUMBER (B)(4) MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 340-000-000, SERIAL/LOT #: (B)(6), UBD: 19-OCT-2021, UDI#: (B)(4). H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE AND PHOTOS WERE AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE BATTERY CELL EXPERIENCED A CRITICAL FAILURE; THE LITHIUM BATTERY CELL CASING HAD BURST OUTWARDS. THE BATTERY ASSEMBLY WAS IN PIECES WITH SECTIONS MISSING. THE MCGRATH HANDLE ALSO EXPERIENCED SUBSTANTIAL DAMAGE WITH PIECES OF THE CASING BROKEN OFF AND THE LIQUID-CRYSTAL DISPLAY SEPARATED FROM THE HANDLE AT THE PIVOT. IT WAS REPORTED THAT THE DEVICE'S BATTERY EXPLODED. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS DETERMINED TO A COMPONENT FAILURE. FURTHER ROOT CAUSE COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE DEVICE'S BATTERY EXPLODED AND THE TABLE TOP WAS BROKEN, THOUGH IT WAS NOT USED. THERE WAS A 'STRONG POWDERY' SMELL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349344 MCGRATH MAC LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-000-000 15060272980020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.