BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2

    MDR report key: 2146007 · Received May 26, 2011

    Report

    Report Number
    3007056120-2011-00013
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR REVIEWED COMPLAINT RECORDS FOR THE LAST TWO (2) YEARS FOR DEVICES WITH THE AFFECTED COMPONENT TO DETERMINE IF ALARM FAILURES HAD PREVIOUSLY OCCURRED. THE COMPLAINT RECORDS REVEALED THERE WERE NO NOTIFICATIONS WITH A LOSS OF AUDIBLE OUTPUT RESULTING FROM A FAULTY SOLDER JOINT ON THE PCB. THE REVIEW DETERMINED THAT NO REPORTS OF ALARM FAILURES FOR THIS ISSUE HAD BEEN PREVIOUSLY REPORTED. BASED ON THE INVESTIGATION AND THESE FINDINGS, THE MFR CONCLUDES THAT NO FURTHER ACTION IS APPROPRIATE. (REVIEW OF COMPLAINT DATABASE).

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER REPORTED THAT AN INFANT APNEA MONITOR FAILED THE SELF CHECKOUT PROCEDURE AND DID NOT ALARM. THE DEVICE WAS NOT IN PT USE AT THE TIME AND THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THE ALLEGED ALARM FAILURE. THE DEVICE WAS RETURNED TO THE MFR WHERE QUALITY ASSURANCE (QA) CONFIRMED THE REPORT THAT THE UNIT FAILED TO PRODUCE AN AUDIBLE ALARM. THE INVESTIGATION DETERMINED THAT THE FAILURE MODE WAS A RESULT OF A DAMAGED SOLDER JOINT OF THE H8 COMPONENT ON THE PRINTED CIRCUIT BOARD (PCB). THE ALARM ASSEMBLY MODULE WAS FOUND TO BE WORKING TO SPECS WHEN TESTED INDEPENDENTLY FROM THE PCB. IT WAS ALSO NOTED DURING THE EVAL THAT THE UNIT WAS RETURNED WITH THE TAMPER SEALS BROKEN. THE MFR REVIEWED THE SERVICE HISTORY OF THE DEVICE AND DETERMINED THAT THE UNIT HAS BEEN IN THE FIELD FOR OVER TWO (2) YEARS WITHOUT ANY PREVIOUS ISSUES BEING REPORTED TO THE MFR, INCLUDING FAILURE TO ALARM. DEVICE LABELING REQUIRES FUNCTIONAL TESTING TO BE PERFORMED PRIOR TO BEING PLACED INTO PT USE TO CONFIRM THAT ALL ALARMS ARE FUNCTIONING AS DESIGNED (SMARTMONITOR 2 CHECKOUT PROCEDURE MANUAL - PN 1020817).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART MONITOR 2 APNEA MONITOR FLS PHILIPS RESPIRONICS, INC. 4003

    Patients

    Seq Age Sex Outcome Treatment
    1