BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS M2601A S02 ECG & SPO2 EASI TELEMETRY TRANSMITTER

    MDR report key: 8777052 · Received July 10, 2019

    Report

    Report Number
    3007409280-2019-00003
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    June 13, 2017
    Report Date
    June 13, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    PMA / PMN Number
    K040357
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO AVANTE HEALTH SOLUTIONS (AHS) FOR EVALUATION; HOWEVER, THE NURSE AT THE HOSPITAL TESTED THE OTHER PHILIPS TELEMETRY TRANSMITTERS RECEIVED IN THE SAME ORDER AS THE COMPLAINT DEVICE. THE NURSE INSERTED A 9V BATTERY BACKWARDS INTO EACH OF THE DEVICES WHICH DUPLICATED THE VERY RAPID OVERHEATING. THE ROOT CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE USE ERROR AS THE BATTERY HAD REPORTEDLY BEEN INSERTED BACKWARDS. IT SHOULD BE NOTED THAT THIS ONLY HAPPENS WITH THE AHS BATTERY CONTACTS AND DID NOT HAPPEN WITH THE PHILIPS BATTERY CONTACTS. THE DEVICE WAS RETURNED TO AHS AND THE AHS BATTERY CONTACTS WERE REPLACED WITH THE PHILIPS BATTERY CONTACTS. NO FURTHER ACTION IS REQUIRED. AVANTE HEALTH SOLUTIONS WILL CONTINUE TO MONITOR THIS TYPE OF EVENT. NOTE: THIS MDR FILING IS PART OF A RETROSPECTIVE REVIEW.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE OVERHEATED, IGNITED AND BURNED SOMEONE AT THE FACILITY. THE CASE OF THE DEVICE ALSO MELTED. IT WAS NOTED THAT RECHARGEABLE BATTERIES WERE NOT BEING USED AND THAT THE ONLY BATTERIES USED IN THE FACILITY ARE MEDCELL BATTERIES FROM (B)(6). THERE WAS NO REPORT OF INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570606 PHILIPS M2601A S02 ECG & SPO2 EASI TELEMETRY TRANSMITTER TELEMENTARY TRANSMITTER MHX PHILIPS MEDICAL SYSTEMS, INC. M2601A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other