BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MINI-HEART

    MDR report key: 20131360 · Received September 3, 2024

    Report

    Report Number
    2028807-2024-00030
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Report Date
    November 6, 2024
    Manufacturer
    WESTMED LLC
    Product Code
    CAF
    UDI-DI
    00709078000232
    PMA / PMN Number
    K920443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 4756-(APPROPRIATE TERM/CODE NOT AVAILABLE): NEBULIZER ADDITIONAL INFORMATION: D4; H6 CORRECTION: H10 THE COMPLAINT INVESTIGATION WAS PERFORMED BASED ON THE CONTENT OF THE ISSUE REPORTED. THE DEVICE HISTORY RECORD FOR LOT 447757 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS NOT AVAILABLE FOR RETURN, ADDITIONALLY, NO PHOTO IMAGES OR VIDEO OF THE REPORTED ISSUE WERE PROVIDED; THEREFORE, THE COMPLAINT WAS UNABLE TO BE CONFIRMED, AND NO ROOT CAUSE WAS IDENTIFIED. ALL INFORMATION REASONABLY KNOWN AS OF 06 NOV 2024 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 SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS 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 SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    4756-(APPROPRIATE TERM/CODE NOT AVAILABLE): NEBULIZER. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 03 SEP 2024 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 SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4) COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    FDA USER FACILITY MW REPORT (B)(4) REPORTED, SOMETIME IN MAY 2024, THE MINIHEART HI-FLO COMPRESSOR NEBULIZER SYSTEM(S) DID NOT NEBULIZE; THE DEVICE WAS APPROXIMATELY 1 DAY OLD. THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    FDA USER FACILITY MW REPORT MW (B)(4) REPORTED, SOMETIME IN (B)(6) 2024, THE MINIHEART HI-FLO COMPRESSOR NEBULIZER SYSTEM(S) DID NOT NEBULIZE; THE DEVICE WAS APPROXIMATELY 1 DAY OLD. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804714 MINI-HEART HI-FLO CONTINUOUS NEBULIZER,ADLT AERO.MASK, 7 CAF WESTMED LLC 100612A ;100612A 447757 00709078000232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown