BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPOTHERM PEDIATRIC NASAL CANNULA

    MDR report key: 1025148 · Received April 4, 2008

    Report

    Report Number
    1125759-2008-00003
    Event Type
    Injury
    Date Received
    April 4, 2008
    Date of Event
    December 19, 2007
    Report Date
    March 27, 2008
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VAPOTHERM BECAME AWARE OF THE EVENT IN 2008 THROUGH OUR FIELD SURVEILLANCE PRACTICE OF A ROUTINE SEARCH OF THE MAUDE DATABASE. VAPOTHERM IS UNABLE TO INVESTIGATE THIS SPECIFIC EVENT AS FDA'S MAUDE DATABASE DOES NOT LIST THE IDENTITY OF THE COMPLAINANT. BECAUSE THE COMPLAINANT DID NOT REPORT THIS EVENT TO VAPOTHERM, VAPOTHERM WAS NOT PROVIDED WITH THE SUBJECT UNIT. HOWEVER, VAPOTHERM PERFORMED A LOT HISTORY REVIEW OF THE LOT FROM WHICH THE SUBJECT WAS PRODUCED. THAT REVIEW INDICATED THAT THE SUBJECT LOT MET ITS SPECIFICATIONS UPON RECEIPT. VAPOTHERM CONDUCTED A REVIEW OF ITS COMPLAINT DATABASE FROM 2004 TO THE PRESENT TO DETERMINE WHETHER SIMILAR EVENTS HAVE OCCURRED. THAT REVIEW YIELDED TWO COMPLAINTS INVOLVING CANNULA DISCONNECT ISSUES. VAPOTHERM'S SUPPLIER, SALTER LABS, IS A MAJOR MFR OF NASAL CANNULAS. SINCE THE CANNULA ASSEMBLY METHOD IS COMMON TO THE MFR OF ALL CANNULAS, A SMALL NUMBER DEFECTIVE CANNULAS IS A INFINITESIMAL PERCENTAGE OF ALL CANNULAS PRODUCED. THE 3 CANNULAS REFERENCED IN THIS MDR ARE FROM TENS OF THOUSANDS SOLD IN OVER 4 YEARS. SALTER LABS WAS NOTIFIED BY VAPOTHERM IN 2004 OF THE DEFECT. THE CAUSE OF THE TUBING DISCONNECT WAS ATTRIBUTED TO IMPROPER BONDING OF THE TUBING TO THE FACE PIECE ON ONE SIDE. SALTER LABS HAD COMMITTED TO AN EXAMINATION OF THEIR MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    VAPOTHERM BECAME AWARE OF THE EVENT IN 2008 THROUGH OUR FIELD SURVEILLANCE PRACTICE OF A ROUTINE SEARCH OF THE MAUDE DATABASE. THE CONTENT OF THE MAUDE REPORT IS AS FOLLOWS: "INFANT FOUND TO BE DESATURATING IN THE 60'S AFTER REQUIRING INCREASED FIO2. VAPOTHERM INFANT NASAL CANNULA FOUND TO HAVE COME APART BETWEEN THE PRONGS AND THE SIDE OF THE CANNULA. CANNULA REMOVED AND A NEW ONE CONNECTED. SATURATIONS IMPROVED TO WITHIN NORMAL LIMITS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM PEDIATRIC NASAL CANNULA CANNULA BTT VAPOTHERM, INC. 122405

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention