BEUDAMED
    FDA Adverse Event Summary report: N

    MOBILAIRE III

    MDR report key: 5886 · Received July 13, 1993

    Report

    Report Number
    5886
    Date Received
    July 13, 1993
    Report Date
    June 8, 1993
    Manufacturer
    INVACARE RESPIRATORY CORP.
    Product Code
    BYK
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    OXYGEN CONCENTRATOR BLEW UP. WAS NOT IN USE AT THE TIME. NO INJURIES OR TREATMENT NECESSARYINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILAIRE III BYK INVACARE RESPIRATORY CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Invalid Data