BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSI FETAL MONITOR F9 (US)

    MDR report key: 15292869 · Received August 25, 2022

    Report

    Report Number
    1216677-2022-00246
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    August 11, 2022
    Report Date
    March 10, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGM
    PMA / PMN Number
    DISCONTINUED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REVIEW DHR X-INSPECT RETURNED SAMPLES ANALYSIS AND FINDINGS. (B)(4). WAS THE COMPLAINT CONFIRMED? YES. DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED BY CSI FROM EDAN INSTRUMENTS INC. ON 03-16-22 AND SOLD ON 04-22-22. MANUFACTURING RECORD REVIEW. MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW IQC RECORD-22-03-18-016 WAS REVIEWED AND NO NON-CONFORMITIES RELATED TO THE COMPLAINT CONDITION WERE NOTED. SERVICE HISTORY RECORD. NO SERVICE HISTORY RECORD WAS FOUND FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW. A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT. THE COMPLAINT PRODUCT (MS9-108022, 1 PC) WAS RETURNED. VISUAL EVALUATION. VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION . COMPLAINT PRODUCT WAS FORWARDED TO THE SUPPLIER FOR EVALUATION OF THE FAILURE MODE. PLEASE SEE THE SUPPLIER'S FULL REPORT IN THE ATTACHMENT. ROOT CAUSE. WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE POTENTIAL CAUSE MAY BE THE USER MAKING A WRONG JUDGMENT (BASED ON THE SUPPLIER EVALUATION). REASON 1: THE DIFFERENCE BETWEEN FETAL HEART AND ABDOMINAL AORTA SOUNDS IS NOT NOTICED. REASON 2: THE POSITION OF THE FETAL HEART SOUGHT AT THE BEGINNING OF MONITORING WAS NOT OPTIMAL; CAUSE 3: DURING SUBSEQUENT CONTINUOUS MONITORING, THE SIGNAL SOURCE WAS NOT CONFIRMED TO BE FROM THE FETUS. *CORRECTION AND/OR CORRECTIVE ACTION / *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER TRAINING REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    STRIP ONE SHOWS THE FINAL REASON WHY WE QUIT USING THE NEW MACHINES DUE TO THE CONFUSION BETWEEN MATERNAL VERSUS FETAL HEART RATE. THIS IS THE PATIENT THAT WAS SENT BY AMBULANCE TO THE HOSPITAL AND EVEN AFTER HAVING NORMAL NST THERE WAS STILL INDUCED FOR DELIVERY BASED ON THE NST STRIP DONE IN OUR OFFICE ON THE NEW COOPER MACHINE. SHE HAD A C-SECTION 36 6/7 WEEKS BECAUSE SHE WAS BREECH. STRIP TWO IS ANOTHER EXAMPLE OF HOW THE NEW MACHINES ARE READING THE MATERNAL HEART RATE VERSUS FETAL HEART RATE. (B)(4).

    Description of Event or Problem · 0

    STRIP ONE SHOWS THE FINAL REASON WHY WE QUIT USING THE NEW MACHINES DUE TO THE CONFUSION BETWEEN MATERNAL VERSUS FETAL HEART RATE. THIS IS THE PATIENT THAT WAS SENT BY AMBULANCE TO THE HOSPITAL AND EVEN AFTER HAVING NORMAL NST THERE WAS STILL INDUCED FOR DELIVERY BASED ON THE NST STRIP DONE IN OUR OFFICE ON THE NEW COOPER MACHINE. SHE HAD A C-SECTION 36 6/7 WEEKS BECAUSE SHE WAS BREECH. STRIP TWO IS ANOTHER EXAMPLE OF HOW THE NEW MACHINES ARE READING THE MATERNAL HEART RATE VERSUS FETAL HEART RATE. 1216677-2022-00246 - MS9-108022 CSI FETAL MONITOR F9 (US) E-COMPLAINT (B)(4).

    Description of Event or Problem · 0

    STRIP ONE SHOWS THE FINAL REASON WHY WE QUIT USING THE NEW MACHINES DUE TO THE CONFUSION BETWEEN MATERNAL VERSUS FETAL HEART RATE. THIS IS THE PATIENT THAT WAS SENT BY AMBULANCE TO THE HOSPITAL AND EVEN AFTER HAVING NORMAL NST THERE WAS STILL INDUCED FOR DELIVERY BASED ON THE NST STRIP DONE IN OUR OFFICE ON THE NEW COOPER MACHINE. SHE HAD A C-SECTION 36 6/7 WEEKS BECAUSE SHE WAS BREECH. STRIP TWO IS ANOTHER EXAMPLE OF HOW THE NEW MACHINES ARE READING THE MATERNAL HEART RATE VERSUS FETAL HEART RATE. 1216677-2022-00246-2 - MS9-108022 CSI FETAL MONITOR F9 (US) - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460578 CSI FETAL MONITOR F9 (US) CSI FETAL MONITOR F9 (US) HGM COOPERSURGICAL, INC. MS9-108022 N/A - NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other