BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON FM30 FETAL MONITOR

    MDR report key: 7074556 · Received December 1, 2017

    Report

    Report Number
    9610816-2017-00378
    Event Type
    Death
    Date Received
    December 1, 2017
    Date of Event
    August 9, 2017
    Report Date
    November 27, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K052795
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REQUESTED ASSISTANCE REGARDING THE INTERPRETATION OF THE TRACES, ESPECIALLY THOSE OBTAINED DURING THE EXPULSION PHASE, TO DETERMINE WHETHER THE MATERNAL HEART RATE (MHR) HAD BEEN MISTAKEN FOR THE FETAL HEART RATE (FHR). THE HEAD MIDWIFE FROM THE HOSPITAL STATED THAT THEY DID NOT QUESTION THE CORRECT OPERATION OF THE EQUIPMENT. THE CUSTOMER REPORTED THAT THE EVENT WAS LIKELY CAUSED BY THE MATERNAL HEART RATE (MHR) BEING MISTAKEN FOR THE FETAL HEART RATE (FHR). THE TRACE TAKEN WITH THE CARDIOTOCOGRAPHY (CTG) AVALON FM30 WAS PROVIDED TO PHILIPS. THE TRACE SHOWED THAT INITIALLY ONLY THE FHR WAS MEASURED WITH AVALON US TRANSDUCER AND NOT THE MHR. LATER, FROM 16:57 ONWARDS, THE MHR WAS MEASURED WITH THE AVALON TOCO MP TRANSDUCER. SHORTLY AFTER, FROM 17:10 ONWARDS THE MHR MEASUREMENT SWITCHED TO A SPO2 SENSOR. THE TRACE WAS ASSESSED BY A PHILIPS PHYSICIAN AND AN EXTERNAL ADVISORY MIDWIFE: THE EVALUATION OF THE PROVIDED TRACE REVEALED THAT AT 18:58 AND 19:00 THE FETAL MONITOR DETECTED THAT THE US TRANSDUCER AND SPO2 PULSE WERE EXHIBITING THE SAME OR SIMILAR VALUES AND, AS A CONSEQUENCE, ISSUED THE COINCIDENCE INOP WITH AN INOP TONE DUE TO THE POSSIBILITY THAT THE US TRANSDUCER HAD RECORDED THE MATERNAL HEART RATE (MHR) INSTEAD OF THE FETAL HEART RATE (FHR). THIS BEHAVIOR IS CONSISTENT WITH A FETAL MONITOR OPERATING AS SPECIFIED AND, THEREFORE, THE INVESTIGATION HAS CONCLUDED THAT NO MALFUNCTION OCCURRED. THE EVALUATION RESULTS WERE PROVIDED TO THE CUSTOMER VIA FORMAL LETTER OF RESPONSE. NO PART NEEDED TO BE REPLACED. THE PRODUCT REMAINS AT THE CUSTOMER SITE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER WAS SEEKING ASSISTANCE REGARDING THE INTERPRETATION OF THE DELIVERY TRACES. THE DEATH OF A BABY TOOK PLACE ON (B)(6) 2017 AT 19:40. THE DEVICE WAS USED FOR MONITORING AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856627 AVALON FM30 FETAL MONITOR FETAL MONITOR HGM PHILIPS MEDICAL SYSTEMS M2703A 49635146

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Death