BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYMED

    MDR report key: 1983113 · Received December 31, 2010

    Report

    Report Number
    1983113
    Event Type
    Malfunction
    Date Received
    December 31, 2010
    Date of Event
    August 11, 2010
    Report Date
    December 31, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS USA, INC.
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S FILEMAKER HOLTER REPORT WAS FAXED TO CLINIC AT RETIREMENT VILLAGE. THE FOLLOWING MORNING, UPON REVIEW OF THE ".ZPT" FILE TO VERIFY THAT IT MATCHED THE DATA IN FILEMAKER, IT WAS DISCOVERED THAT ANOTHER PATIENT'S DATA HAD MERGED INTO THIS PATIENT'S REPORT. AT THIS POINT, THE INFORMATION WAS REVIEWED WITH AN EP PHYSICIAN, WHO FELT THAT NO HARM WOULD BE DONE TO THE PATIENT FROM THE INCORRECT DATA. THE OUTSIDE CLINIC WAS CALLED TO INFORM THEM OF THE ISSUE AND THE CORRECTED REPORT WAS FAXED. THE FIRST REPORT SHOWED AVERAGE HEART RATE OF 73 WITH MINIMUM OF 51 BEATS PER MINUTE AND MAXIMUM OF 107. THE AMENDED REPORT NOTED AVERAGE HEART RATE IN THE 50'S WITH A MAXIMUN OF 90 BEATS PER MINUTE. THE PATIENT DID HAVE BRADYCARDIA AT 0200 WITH THE LOWEST HEART RATE OF 32. PATIENT HAD EPISODES OF JUNCTIONAL ESCAPE RHYTHM.PHYSICIAN FELT THERE WAS NO HARM ASSOCIATED WITH THIS EVENT. MERGING APPEARS TO HAPPEN WHEN IMPORTING DATA INTO FILEMAKER FROM TWO SATELLITE CLINICS AT THE SAME TIME. THERE IS NO MAINTENANCE ON THE PHILIPS SCANNERS, EXCEPT FOR SOFTWARE UPDATES. THE SOFTWARE HAD RECENTLY BEEN UPDATED ON THE SCANNERS PRIOR TO THIS EVENT. WHEN PROBLEMS ARE ENCOUNTERED, THE SOFTWARE IS RE-INSTALLED. MERGING APPEARS TO ONLY HAPPEN DURING FILEMAKER IMPORTATION AND IT IS DIFFICULT TO DETERMINE IF THE GLITCH IS WITH FILEMAKER OR PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYMED HOLTER ANALYSIS WORKSTATION, SOFTWARE DQK PHILIPS MEDICAL SYSTEMS USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR