BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGEL PRP SYSTEM CENTRIFUGE US (NEW)

    MDR report key: 16494378 · Received March 7, 2023

    Report

    Report Number
    1220246-2023-06391
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    December 28, 2022
    Report Date
    May 5, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    ORG
    UDI-DI
    00888867083974
    PMA / PMN Number
    BK110046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. UPON VISUAL INSPECTION, NO PROBLEMS WERE NOTED WITH THE DEVICE. A BURNING SMELL WAS NOTED TO BE COMING FROM THE DEVICE. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO POTENTIAL HAZARDS WITH BURNING SMELL PRESENT.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10060 ANGEL CENTRIFUGE STOPPED WORKING. THE FACILITY STATED THEY SMELLED A BURNING SMELL, THE PLATE WOULD NOT SPIN, AND THE SCREEN WENT BLACK. THIS WAS DISCOVERED DURING A CLINIC PRP INJECTION. DUE TO THIS ISSUE, THE PATIENT WAS SENT HOME AND NO PRP INJECTION OCCURRED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86101 ANGEL PRP SYSTEM CENTRIFUGE US (NEW) PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING ORG ARTHREX, INC. ANGEL PRP SYSTEM CENTRIFUGE US (NEW) 11101210 00888867083974

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown