BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRWAY MOBILESCOPE

    MDR report key: 11424171 · Received March 5, 2021

    Report

    Report Number
    8010047-2021-03377
    Event Type
    Injury
    Date Received
    March 5, 2021
    Report Date
    March 5, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170340369
    PMA / PMN Number
    K082720
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION, THEREFORE PHYSICAL EVALUATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICE(S) COULD NOT BE PERFORMED SINCE NO SERIAL NUMBER/LOT NUMBER WAS PROVIDED, HOWEVER OLYMPUS DOES NOT SHIP AND DEVICE THAT DOES NOT MEET ALL DESIGN/SAFETY SPECIFICATIONS. CONCLUSION. THE DEFINITIVE CAUSE OF THE REPORTED EVENTS COULD NOT BE ESTABLISHED. THIS STUDY'S AIM WAS TO DETERMINE THE INCIDENCE, MANAGEMENT, AND OUTCOMES OF PATIENTS WITH PREDICTED DIFFICULT AIRWAYS IN THE ED EMERGENCY DEPARTMENT. THERE WAS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION. HIS EVENT HAS BEEN REPORTED BY THE IMPORTER ON MDR# 2951238 - 2021 - 00298.

    Description of Event or Problem · 1

    IT IS REPORTED IN THE LITERATURE ARTICLE TITLED "MANAGEMENT OF PATIENTS WITH PREDICTED DIFFICULT AIRWAYS IN AN ACADEMIC EMERGENCY DEPARTMENT ", TWO OF SEVEN PATIENTS FROM THE AWAKE GROUP HAD AIRWAY INTUBATION PERFORMED USING OLYMPUS MAF-GM. FIVE PATIENTS FROM THIS GROUP EXPERIENCED ADVERSE EVENTS (HYPOXIA-2, DYSRHYTHMIA-2, AND PERI-INTUBATION ARREST-1). THERE IS NO SPECIFIC INFORMATION AVAILABLE TO CLARIFY WHICH (IF ANY) OF THE FIVE PATIENTS EXPERIENCING AN ADVERSE EVENT WERE INTUBATED USING THE MAF-GM. IT IS REPORTED THAT ALL PATIENTS IN THIS STUDY WERE PREDICTED TO HAVE DIFFICULT AIRWAYS TO INTUBATE. IT IS ALSO REPORTED THAT NO PATIENT IN THIS STUDY REQUIRED SURGICAL AIRWAY INTERVENTION. THIS REPORT IS BEING SUBMITTED TO REPORT THE POTENTIAL THAT AN OLYMPUS DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT IN EITHER OF THE TWO PATIENTS THAT WERE INTUBATED USING THE MAF-GM. THERE IS NO REPORT THAT THE MAF-GM MALFUNCTIONED IN ANY WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318354 AIRWAY MOBILESCOPE AIRWAY MOBILESCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. MAF-GM 04953170340369

    Patients

    Seq Age Sex Outcome Treatment
    1 Other