BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOREANYWHERE

    MDR report key: 5440767 · Received February 17, 2016

    Report

    Report Number
    2518422-2016-00699
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Date of Event
    May 24, 2015
    Report Date
    April 28, 2016
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K993307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED THE BIPAP FOR INVESTIGATION AND THERE WERE NO OPERATIONAL ISSUES NOTED. THERE WAS NO EVIDENCE OF A FAILURE OF THE DEVICE THAT WOULD HAVE RESULTED IN PATIENT DATA FROM A PREVIOUS PATIENT BEING INCLUDED IN ANOTHER PATIENT'S DATA. THE ROOT CAUSE OF THE EVENT IS DUE TO THE OPERATOR OF THE DEVICE NOT CLEARING THE MEMORY FOR THE BIPAP AND ASSOCIATED MODEM AND SD CARD. THE MODEM MANAGEMENT USER GUIDE (PN 1109520) INSTRUCTS THE USER, "BE SURE TO CLEAR THE MEMORY OF ANY PREVIOUSLY USED THERAPY DEVICES, MODEMS, SMARTCARDS OR SD CARDS PRIOR TO REISSUING THEM TO OTHER PATIENTS. CONSULT THE DOCUMENTATION INCLUDED WITH THE THERAPY DEVICE OR MODEM FOR INSTRUCTIONS ON CLEARING ITS MEMORY. USE THE DATA CARD UTILITIES TO CLEAR THE MEMORY OF SMARTCARDS AND SD CARDS. THE DATA CARD SERVER MUST BE INSTALLED AND RUNNING ON YOUR COMPUTER IN ORDER TO ACCESS DATA CARD UTILITIES. THE DATA CARD SERVER UTILITY FOR INSTALLATION CAN BE FOUND BY CLICKING ON THE ENCOREANYWHERE PRE-REQUISITES PAGE HYPERLINK ON THE LOGIN PAGE FOR ENCOREANYWHERE." THERE WAS NO PATIENT INVOLVEMENT, AND NO RISK OF HARM OR INJURY IF THE EVENT SHOULD RECUR. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS MADE AWARE OF AN ALLEGATION BY A CUSTOMER THAT ENCORE ANYWHERE (EA) SOFTWARE WAS RESPONSIBLE FOR DATA FROM ONE PATIENT BEING INCLUDED IN ANOTHER PATIENT'S DATA WHEN DOWNLOADED FROM AN A30 BI-LEVEL POSITIVE AIRWAY PRESSURE (BIPAP) DEVICE. THERE WAS NO DIRECT PATIENT INVOLVEMENT, AND NO PATIENT HARM OR INJURY WAS REPORTED. THE ALLEGED INCIDENT OCCURRED ON (B)(6) 2015, BUT WAS NOT COMMUNICATED TO THE MANUFACTURER UNTIL 01/21/2016. THE MANUFACTURER HAS REQUESTED RETURN OF THE A30 BIPAP, SN (B)(4), MATERIAL NUMBER (B)(4) FOR INVESTIGATION IN THIS ALLEGED EVENT. THE MANUFACTURER IS CURRENTLY INVESTIGATING THIS ALLEGATION. PRELIMINARY ASSESSMENT OF THE DOWNLOADED DATA INDICATES THAT THE CUSTOMER DID NOT CORRECTLY ERASE THE MEMORY OF THE THERAPY DEVICE AFTER THE DEVICE WAS REMOVED FROM THE FIRST PATIENT, THUS ALLOWING ADDITIONAL DATA FROM THE FIRST PATIENT TO BE INCLUDED IN THE SECOND PATIENT'S DATA. THE MANUFACTURER'S INVESTIGATION ON-GOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION. NOTE THAT THIS SOFTWARE IS ASSOCIATED WITH THESE 510(K) NUMBERS: K993307, K012323, K061034 AND K121623.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98666 ENCOREANYWHERE DATA MANAGEMENT SOFTWARE BZD RESPIRONICS, INC. 1039435 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1