BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON FETAL & MATERNAL PATCH

    MDR report key: 23191392 · Received October 1, 2025

    Report

    Report Number
    1218950-2025-000565
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    October 8, 2024
    Report Date
    October 28, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HFM
    PMA / PMN Number
    K140535
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INVOLVEMENT WAS REPORTED, THE BABY WAS BORN 'FLAT' WITH POTENTIAL HYPOXIC-ISCHEMIC ENCEPHALOPATHY DUE TO POOR CORD GASES AT BIRTH, WHICH REQUIRED ACTIVE RESUSCITATION AND NICU ADMISSION WITH CPAP. RECOVERY WAS SUBSEQUENTLY NORMAL AND THE BABY WAS DISCHARGED HOME A FEW DAYS LATER. THE CUSTOMER SPOKE TO A PHILIPS CLINICAL CONSULTANT STATING THAT THE POD AND PATCH WAS IN USE BUT NOT PICKING UP WELL AND FETAL HEART / CONTRACTIONS NOT ADEQUATELY MONITORED FOR A SUBSTANTIAL DURATION IN A PROLONGED 2ND STAGE, WITH BABY BORN IN POOR CONDITION. THE CUSTOMER STATED THAT IT'S NOT AN ISSUE WITH THE POD AND PATCH BUT MORE A LACK OF SITUATIONAL AWARENESS. NO DIAGNOSTIC/FUNCTIONAL TESTING COULD BE PERFORMED AS THE CASE WAS REPORTED ALMOST A YEAR LATER. SEVERAL ATTEMPTS WERE MAD TO GET ADDITIONAL INFORMATION, BUT THE CUSTOMER'S ONLY RESPONSE WAS THERE WAS NOTHING WRONG WITH THE PRODUCT AND THEY ONLY NEEDED TO ORDER NEW BATTERIES. BASED ON THIS INFORMATION, THERE DOES NOT APPEAR TO BE A MALFUNCTION THAT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT; HOWEVER, THE 'SITUATIONAL AWARENESS' MENTIONED BY THE CUSTOMER MAY BE RELATED TO A USE ERROR, THOUGH THE ACTUAL CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. B3: DATE OF EVENT: UPDATE TO 10/08/2024. PREVIOUSLY REPORTED INCORRECTLY AS 09/08/2024

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. REPORTING INSTITUTION PHONE # (B)(6). REPORTER PHONE # (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE DID NOT DETECT THE FETAL HEART RATE AND CONTRACTIONS ADEQUATELY DURING A PROLONGED 2ND STAGE LABOR WITH A FETUS IN POOR CONDITION. THE POD AND PATCH WERE USED INITIALLY AS THE MIDWIFE WAS UNABLE TO RECORD THE CONTRACTIONS ADEQUATELY ON CTG, SO IT WAS THOUGH THIS SYSTEM WOULD BE USED AS THE MOTHER, WHO HAD BEEN INDUCED, WAS MOBILE AND IN THE SHOWER. THE MOTHER WAS A NORMAL BMI AND A HIGH-RISK LABOR. IT WAS INDICATED "IT'S NOT AN ISSUE WITH THE POD AND PATCH BUT MORE OF A LACK OF SITUATIONAL AWARENESS". THE POD AND PATCH SYSTEM DID NOT IMPROVE THE QUALITY OF RECORDING OVER A TWO-HOUR PERIOD. THE CUSTOMER INDICATED THIS ISSUE WAS NOT PROPERLY ESCALATED PER PROTOCOL OR ALTERNATIVE MONITORING IMPLEMENTED. IT WAS UNKNOWN WHETHER THE INITIAL CONNECTION WAS SATISFACTORY. THE BABY WAS BORN 'FLAT' WITH POTENTIAL HYPOXIC-ISCHEMIC ENCEPHALOPATHY DUE TO POOR CORD GASES AT BIRTH, WHICH REQUIRED ACTIVE RESUSCITATION AND NICU ADMISSION WITH CPAP. RECOVERY WAS SUBSEQUENTLY NORMAL AND THE BABY WAS DISCHARGED HOME A FEW DAYS LATER. GOOD FAITH EFFORTS ARE BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659537 AVALON FETAL & MATERNAL PATCH AVALON CL FETAL & MATERNAL PATCH HFM PHILIPS MEDICAL SYSTEMS 989803196341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other