BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BT37 BENCHTOP INCUBATOR

    MDR report key: 8808568 · Received July 19, 2019

    Report

    Report Number
    1216677-2019-00209
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    June 11, 2019
    Report Date
    October 3, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MQG
    PMA / PMN Number
    K121566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE: E-COMPLAINT-(B)(4). INVESTIGATION: X-INSPECTED RETURNED SAMPLES. ANALYSIS AND FINDING: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY FOR THE BT37 BENCHTOP INCUBATOR SHOWS NO SIMILAR COMPLAINTS ON FILE. THIS IS AN ISOLATED EVENT. THE BT37 BENCHTOP INCUBATOR IS A PURCHASED PRODUCT AND IS A DOCK TO STOCK ITEM. UPON INVESTIGATION OF THE RETURNED BT37 BENCHTOP INCUBATOR, IT REVEALED A DEAD BATTERY, A NONFUNCTIONING POWER SUPPLY, AND A BURNT MOTHER BOARD AND IT ALSO NEEDED LID GASKET UPDATES. THE COMPLAINT CONDITION WAS CONFIRMED. COOPERSURGICAL'S SERVICE AND REPAIR DEPARTMENT REPLACED BATTERY, POWER SUPPLY AND MAIN CIRCUIT BOARD, AND PERFORMED ROUTINE MAINTENANCE BY REPLACING LID GASKETS, CAM HANDLE ASSEMBLY, FILTER AND LATCH ASSEMBLY. THE SERVICED BT37 BENCHTOP INCUBATOR WAS CALIBRATED AND TESTED TO QUALITY SPECIFICATION AND THEN RETURNED TO THE CUSTOMER. REFERENCE REPAIR ORDER# (B)(4). ROOT CAUSE CANNOT BE RELIABLY DETERMINED AT THIS TIME AND IT IS MOST LIKELY ATTRIBUTED TO IMPROPER HANDLING. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS. CORRECTION AND/OR CORRECTIVE ACTION: NONE. REASON: NO CHANGES TO THE PROCESS OR PROCEDURE. WAS THE COMPLAINT CONFIRMED? YES. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION IN THE COOPERSURGICAL CIP (CONTINUOUS IMPROVEMENT PROGRAM) PROGRAM FOR ANY TRENDS, AS A PRODUCT MALFUNCTION ONLY. BASED ON THE ANALYSIS OF THE DEVICE, ALL CURRENT AND AVAILABLE INFORMATION RECEIVED AND INVESTIGATION FINDINGS IT HAS BEEN DETERMINED THAT THE DESCRIBED CONDITION IS NOT A REPORTABLE EVENT.

    Description of Event or Problem · 0

    2PN ARREST. TOTAL CLEAVAGE ARREST BETWEEN DAY1 AND DAY2. REF E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    2PN ARREST. TOTAL CLEAVAGE ARREST BETWEEN DAY1 AND DAY2. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600171 BT37 BENCHTOP INCUBATOR BT37 BENCHTOP INCUBATOR MQG COOPERSURGICAL, INC. BT37 24477

    Patients

    Seq Age Sex Outcome Treatment
    1 Other