BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT PROFILE PRIME PLUS ANALYZER SYSTEM

    MDR report key: 12541450 · Received September 28, 2021

    Report

    Report Number
    1219029-2021-00032
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    August 30, 2021
    Report Date
    March 30, 2022
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    CHL
    UDI-DI
    00385480574006
    PMA / PMN Number
    K193246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS CURRENTLY A PENDING INVESTIGATION. NOVA BIOMEDICAL IS REQUESTING ADDITIONAL INFORMATION, AND FURTHER DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). THE CUSTOMER REPORTED A BURNING SMELL AND SMOKE WAS PRODUCED BY A STAT PROFILE PRIME PLUS BENCHTOP ANALYZER WITH SERIAL NUMBER: (B)(6). THIS OCCURRED ON (B)(6) 2021. THE ANALYZER DID NOT INDICATE THERE WAS A PROBLEM. THE CUSTOMER INDICATED THE ANALYZER WAS POWERED OFF AND TAKEN OUT OF SERVICE IMMEDIATELY WITH NO IMPACT ON PATIENT CARE. THE CUSTOMER ALSO INDICATED THE POWER SUPPLY CABLE HAD BEEN DROPPED THE DAY PRIOR TO THE INCIDENT WHICH CAUSED A MECHANICAL STRAIN ON THE ANALYZER. THE DISTRIBUTOR IDENTIFIED THE CIRCUIT BOARD WHICH HAD CAUSED THE SMOKE AND RETURNED IT TO NOVA BIOMEDICAL FOR INVESTIGATION. THE BOARD WAS IDENTIFIED AS NOT BEING THE ORIGINAL PART INSTALLED ON THE ANALYZER AT THE TIME OF MANUFACTURE. A PREVIOUS ENGINEERING CHANGE ORDER REQUIRED THE PLACEMENT OF KAPTON TAPE OVER PARTICULAR LEADS ON THE BOARD TO PREVENT POTENTIAL ELECTRICAL SHORTS WITH THE METAL CHASSIS OF THE INSTRUMENT. THE RETURNED BOARD WAS VOID OF THIS TAPE. FURTHER INVESTIGATION INCLUDED TESTING MULTIPLE BOARDS UNDER DIFFERENT FACTORS INCLUDING MECHANICAL STRESS AND EXCESSIVE HEAT. AFTER THESE TESTS, THE REPORTED PROBLEM COULD NOT BE REPRODUCED WHEN THE KAPTON TAPE WAS PRESENT. DEVICE HISTORY RECORD (DHR) REVIEWS WERE PERFORMED FOR THE ANALYZER BY A QUALITY CONTROL ENGINEER. THE REVIEWS INCLUDED AN ASSESSMENT OF THE PRODUCTION, TESTING, AND RELEASE OF THE METER AND TEST STRIP BATCH. NO ABNORMALITIES OR CONCERNS WERE NOTED, AND THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. THE CONCLUSION OF THE INVESTIGATION IS THE REPORTED CUSTOMER COMPLAINT COULD NOT BE REPRODUCED AFTER TESTING THE RETURNED CIRCUIT BOARD AND THE MANUFACTURER RETAINS OF SIMILAR CIRCUIT BOARDS. A CONCLUSIVE ROOT CAUSE WAS UNABLE TO BE IDENTIFIED, AND NOVA WILL CONTINUE TO MONITOR FOR RECURRENCE OF SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    THERE IS CURRENTLY A PENDING INVESTIGATION. NOVA IS REQUESTING ADDITIONAL INFORMATION, AND FURTHER DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THERE IS CURRENTLY A PENDING INVESTIGATION. NOVA IS REQUESTING ADDITIONAL INFORMATION, AND FURTHER DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THERE IS CURRENTLY A PENDING INVESTIGATION. NOVA IS REQUESTING ADDITIONAL INFORMATION, AND FURTHER DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    NOVA BIOMEDICAL CORPORATE WAS MADE AWARE OF A POTENTIAL PRODUCT MALFUNCTION USING A STAT - PROFILE PRIME PLUS BENCHTOP ANALYZER, SERIAL NUMBER (B)(6). IT WAS REPORTED THE ANALYZER WAS PRODUCING A BURNING SMELL AND SMOKE WAS COMING FROM THE MACHINE. THE ANALYZER WAS IMMEDIATELY TAKEN OUT OF SERVICE AND REMOVED FROM THE FACILITY. THERE WAS NO IMPACT ON PATIENT OR USER SAFETY.

    Additional Manufacturer Narrative · 1

    THERE IS CURRENTLY A PENDING INVESTIGATION. NOVA IS REQUESTING ADDITIONAL INFORMATION, AND FURTHER DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    NOVA BIOMEDICAL CORPORATE WAS MADE AWARE OF A POTENTIAL PRODUCT MALFUNCTION USING A STATPROFILE PRIME PLUS BENCHTOP ANALYZER, SERIAL NUMBER (B)(4). IT WAS REPORTED THE ANALYZER WAS PRODUCING A BURING SMELL AND SMOKE WAS COMING FROM THE MACHINE. THE ANALYZER WAS IMMEDIATELY TAKEN OUT OF SERVICE AND REMOVED FROM THE FACILITY. THERE WAS NO IMPACT ON PATIENT OR USER SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439766 STAT PROFILE PRIME PLUS ANALYZER SYSTEM BLOOD GASES (PCO2, PO2) AND BLOOD PH TEST SYSTEM CHL NOVA BIOMEDICAL CORP. PRIME PLUS 00385480574006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown