BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIOPERFECT WORKSTATION (CPWS)

    MDR report key: 2573861 · Received May 4, 2012

    Report

    Report Number
    1316463-2012-00002
    Event Type
    Other
    Date Received
    May 4, 2012
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    WELCH ALLYN
    Product Code
    BZG
    PMA / PMN Number
    K082478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE FACILITY TO OBTAIN ADDITIONAL INFO ABOUT THIS ALLEGATION WITHOUT SUCCESS. THE FLOW TRANSDUCER USED ON THE AFOREMENTIONED PT WAS NOT MADE AVAILABLE TO WELCH ALLYN FOR EVALUATION. THE DISTRIBUTOR INDICATED THE PT WAS WRONGLY INSTRUCTED TO BITE DOWN ON THE FLOW TRANSDUCER BY THE CLINICIAN. WELCH ALLYN DOES NOT KNOW WHAT THE FOREIGN MATERIAL WAS OR HOW IT MADE IT'S WAY INTO THE FLOW TRANSDUCER. WELCH ALLYN PURCHASES AND DISTRIBUTES THE SPIROPERFECT KIT (CATALOG NUMBER 703554) AND SINGLE-FLOW TRANSDUCERS (CATALOG NUMBERS 703418 (25 PK) AND 703419 (100 PK)) FROM (B)(4). WELCH ALLYN INFORMED (B)(4) IN WRITING OF THIS EVENT ON 03/14/2011; (B)(4) ORIGINALLY SUBMITTED A MEDICAL DEVICE REPORT ON OR ABOUT 04/07/2011. METHOD CODE (OTHER) - OTHER DEVICE NOT RETURNED, UNABLE TO CONFIRM ALLEGATION.

    Description of Event or Problem · 1

    WELCH ALLYN WAS MADE AWARE, THROUGH A DISTRIBUTOR (B)(6), THAT AN UNKNOWN FOREIGN OBJECT WAS IN THE DISPOSABLE SPIROMETER FLOW TRANSDUCER. TWICE THE PT HAD THE OBJECT ENTER HER MOUTH AT THE START OF THE PROCEDURE, BUT NO REPORT OF THE OBJECT GOING INTO THE PT'S WINDPIPE/TRACHEA. THE PT SPAT THE OBJECT OUT AND CONTINUED WITH THE PROCEDURE. THERE WAS NO REPORT OF ANY INJURY AS A RESULT OF THIS EVENT AND NO REPORT THAT PT INHALED THE OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOPERFECT WORKSTATION (CPWS) BZG WELCH ALLYN SPIROPERFECT KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR