BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER

    MDR report key: 9131231 · Received September 27, 2019

    Report

    Report Number
    3011270181-2019-00040
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    August 30, 2019
    Report Date
    November 27, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BYD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 27-NOV-2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MEDLINE PATIENT CIRCUIT AND A COVIDEN SHILEY HI-LO ORAL/NASAL TRACHEAL TUBE CUFFED. THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 26-SEP-2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE TWO OF FOUR REPORTS. REFER TO 3011270181-2019-00039 FOR THE FIRST EVENT. REFER TO 3011270181-2019-00041 FOR THE THIRD EVENT. REFER TO 3011270181-2019-00042 FOR THE FOURTH EVENT. IT WAS REPORTED THAT THE VENTILATOR GAVE A BREATH AND IT [HEAT MOISTURE EXCHANGE (HME)] POPPED OFF. THE DEVICE WAS RECONNECTED AND IT POPPED OFF AGAIN. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 06-SEP-2019 STATED THE, "ANESTHETISTS WERE VIGILANT OF THEIR PATIENTS AND VENTILATOR CUES AND AS SOON AS THE PRODUCT BECAME UNATTACHED IT WAS PLACED BACK ON AND ONCE IT HAPPENED ON THE NEXT BREATH" THE DEVICE WAS REPLACED. THERE WAS NO REPORTED INJURY. THE DEVICE WAS REPLACED FOR A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925722 BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES BYD AVANOS MEDICAL INC. 150 20-1904-158

    Patients

    Seq Age Sex Outcome Treatment
    1