BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTMONITOR 2 WITH PCMCIA CARD SLOT

    MDR report key: 4622795 · Received March 23, 2015

    Report

    Report Number
    1218950-2015-01623
    Event Type
    Injury
    Date Received
    March 23, 2015
    Report Date
    February 26, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A COMPLETE REVIEW OF THE COMPLAINT ALLEGATION, PHILIPS HEALTHCARE HAS DETERMINED THAT THE REPORTED ISSUE REQUIRES FURTHER INVESTIGATION. THE DEVICE MANUFACTURER IS WORKING WITH THE DME IN ORDER TO OBTAIN THE DEVICE FOR EVALUATION. ONCE THE DEVICE EVALUATION IS COMPLETE OR ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP ADDITIONAL INFORMATION REPORT WILL BE FILED TO DETAIL THE FINDINGS AND THE NEED FOR ANY POSSIBLE FURTHER ACTION.

    Additional Manufacturer Narrative · 1

    THE TYPE OF REPORTED COMPLAINT HAS BEEN CHANGED FROM NON-ADVERSE EVENT TO SERIOUS INJURY BECAUSE IT WAS REPORTED THAT THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND THERE IS NO INFORMATION SUPPORTING THAT EMERGENT CARE WAS NOT REQUIRED FOR THE PATIENT. THIS COMPLAINT WAS INADVERTENTLY NOT CLASSIFIED AS A SERIOUS INJURY PREVIOUSLY DUE TO AN OVERSIGHT. PHILIPS HEALTHCARE HAS RECEIVED THE DEVICE BACK FOR EVALUATION AND NO OBSERVATIONS SUBSTANTIATING A MALFUNCTION OR OTHER OPERATION OUTSIDE OF DESIGN SPECIFICATIONS WERE MADE DURING THE EVALUATION. THE DEVICE WAS FOUND TO OPERATE AND ALARM WITHIN SPECIFICATIONS TO NOTIFY A CAREGIVER OF A POTENTIAL EVENT. THE CUSTOMER STATED THAT PARENTS THAT WERE USING THE DEVICE STATED THAT THERE WAS AN APNEA EVENT THAT THE UNIT DID NOT ALARM FOR AND THAT THE CHILD HAD TO BE TAKEN TO THE HOSPITAL. THE PATIENT HAS SINCE BEEN RELEASED FROM THE HOSPITAL WITH NO LASTING IMPACT. PHILIPS HEALTHCARE HAS DETERMINED THAT THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS NOT OBSERVED DURING THE MANUFACTURER¿S EVALUATION OF THE PRODUCT. PHILIPS HEALTHCARE HAS RECEIVED THE DEVICE BACK FOR EVALUATION AND NO OBSERVATIONS SUBSTANTIATING A MALFUNCTION OR OTHER OPERATION OUTSIDE OF DESIGN SPECIFICATIONS WERE MADE DURING THE EVALUATION. THE DEVICE WAS FOUND TO OPERATE AND ALARM WITHIN SPECIFICATIONS TO NOTIFY A CAREGIVER OF A POTENTIAL EVENT. THE DEVICE HAS BEEN TESTED AND RETURNED TO THE CUSTOMER. THERE HAVE BEEN NO FURTHER RELATED CALLS, SUGGESTING THE PROBLEM HAS NOT RECURRED.

    Description of Event or Problem · 1

    PHILIPS HEALTHCARE RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER DETAILING A SMART MONITOR 2 INFANT APNEA MONITOR FAILED TO ALARM FOR AN APNEA EVENT WHILE ON A PATIENT. IT WAS REPORTED THAT THE INCIDENT OCCURRED IN (B)(6) 2014, BUT THE DEVICE MANUFACTURER WAS ONLY NOTIFIED OF THE INCIDENT ON (B)(6) 2015. IT WAS ALSO REPORTED THAT THE PATIENT WAS TRANSPORTED TO THE HOSPITAL FOLLOWING THE INCIDENT. THERE IS NO LASTING IMPACT ON THE PATIENT ALLEGED.

    Description of Event or Problem · 1

    PHILIPS HEALTHCARE RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER DETAILING A SMART MONITOR 2 INFANT APNEA MONITOR FAILED TO ALARM FOR AN APNEA EVENT WHILE ON A PATIENT. IT WAS REPORTED THAT THE INCIDENT OCCURRED IN (B)(6) OF 2014, BUT THE DEVICE MANUFACTURER WAS ONLY NOTIFIED OF THE INCIDENT ON (B)(6) 2015. IT WAS ALSO REPORTED THAT THE PATIENT WAS TRANSPORTED TO THE HOSPITAL FOLLOWING THE INCIDENT. THERE IS NO LASTING IMPACT ON THE PATIENT ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194368 SMARTMONITOR 2 WITH PCMCIA CARD SLOT APNEA MONITOR FLS PHILIPS MEDICAL SYSTEMS 4002

    Patients

    Seq Age Sex Outcome Treatment
    1