BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G85 MINI INCUBATOR WITH

    MDR report key: 16991858 · Received May 24, 2023

    Report

    Report Number
    1216677-2023-00086
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    March 16, 2023
    Report Date
    June 15, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    PUB
    UDI-DI
    00888937025057
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY. THE COMPLAINT PRODUCT WAS PURCHASED BY CSI (VENLO) FROM ORIGIO - OLSTYKKE. MANUFACTURING RECORD REVIEW. MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW. INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD. SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW. A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT. THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL AS THIS IS A FIELD SERVICE COMPLAINT. VISUAL EVALUATION. THIS IS A FIELD SERVICE COMPLAINT, THERE WAS NO PRODUCT RETURNED FOR EVALUATION. IF FURTHER INFORMATION BECOMES AVAILABLE AT A LATER DATE THIS INVESTIGATION WILL BE AMENDED ACCORDINGLY. FUNCTIONAL EVALUATION. THIS IS A FIELD SERVICE COMPLAINT, THERE WAS NO PRODUCT RETURNED FOR EVALUATION. IF FURTHER INFORMATION BECOMES AVAILABLE AT A LATER DATE THIS INVESTIGATION WILL BE AMENDED ACCORDINGLY. ROOT CAUSE. THIS IS A FIELD SERVICE COMPLAINT, (B)(4). THERE WAS NO PRODUCT RETURNED FOR EVALUATION. IF FURTHER INFORMATION BECOMES AVAILABLE AT A LATER DATE THIS INVESTIGATION WILL BE AMENDED ACCORDINGLY. WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THIS ISSUE MAY HAVE BEEN DUE TO INSTALLATION AND END USER ERROR. THIS IS AN ISOLATED INCIDENT. WHILE INVESTIGATING THIS COMPLAINT IT WAS DETERMINED THAT THE REPORTED CONDITION WAS NOT RELATED TO EMBRYO DAMAGE. THE POTENTIAL RISK WAS TO THE END USER. REPORTABILITY REASSESSMENT WITH UPDATED INFORMATION WAS DETERMINED ON 5/18/2023.

    Description of Event or Problem · 0

    IN AN ATTEMPT TO GET THE GAS FLOW RUNNING, PURGE WAS PRESSED, AND THE BOTTLE LID BLEW OFF. THE REGULATOR WAS AT OVER 1 BAR, WHEREAS THE MANUAL STATES IT SHOULD BE LESS THAN 0.5 BAR. THEN, WHILE REMOVING THE INLET TUBE, THE WELDED BOTTLE JOIN BROKE OFF. 1216677-2023-00086 G85 MINI INCUBATOR K22074 (B)(4).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089318 G85 MINI INCUBATOR WITH G85 MINI INCUBATOR WITH PUB COOPERSURGICAL, INC. K22074 N/A 00888937025057

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other