BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROPERFECT

    MDR report key: 2575140 · Received April 13, 2011

    Report

    Report Number
    1316463-2011-00016
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 10, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MEDIKRO OY
    Product Code
    BZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPIROSAFE FLOW TRANSDUCER IS A ONE PIECE CONSTRUCTION AND IT DOES NOT HAVE ANY MOVING PARTS. IT IS A SINGLE-USE ONLY PRODUCT AND IF IT HAS BEEN USED MORE THAN ONCE (B)(4) CANNOT GUARANTEE ITS FUNCTIONALITY.

    Description of Event or Problem · 1

    WELCH ALLYN (B)(6) REC'D A COMPLAINT AGAINST THE SPIROMETER FLOW TRANSDUCER, WELCH ALLYN PART NUMBER 703419, ON (B)(6) 2011. WELCH ALLYN BECAME AWARE THROUGH A DISTRIBUTOR (B)(4) THAT THEIR CUSTOMER EXPERIENCED A PROBLEM WITH THE FLOW TRANSDUCERS. TWICE WHEN SHE WANTED A PT TO INHALE TO START THE SPIROMETER MEASUREMENTS A FOREIGN OBJECT ENDED UP IN THE PT'S MOUTH. THERE WERE NO INJURIES AS A RESULT OF THESE EVENT AND NO REPORT OF THE OBJECT GOING INTO THE PT'S WINDPIPE/TRACHEA. WELCH ALLYN CONTACTED THE COMPLAINANT AND REQUESTED THE DEVICES TO BE RETURNED FOR FURTHER EVAL. IF WELCH ALLYN WILL RECEIVE THE DEVICES, THEY WILL FORWARD THEM TO (B)(6) FOR FURTHER EVAL. TO THIS DAY (B)(6) 2011, (B)(4) HAS NOT REC'D THE DEVICES. WELCH ALLYN HAS INFORMED FDA ABOUT THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIROPERFECT DIAGNOSTIC SPIROMETER BZG MEDIKRO OY SPIROPERFECT USB

    Patients

    Seq Age Sex Outcome Treatment
    1