BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500

    MDR report key: 4905778 · Received July 10, 2015

    Report

    Report Number
    1217157-2015-00095
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    December 18, 2014
    Report Date
    December 18, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KHP
    PMA / PMN Number
    K113216
    Removal / Correction Number
    1217157-07-24-2015-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE URGENT FIELD SAFETY NOTICE (33114 REV. A) HAS BEEN ISSUED TO NOTIFY ALL AFFECTED SIEMENS CUSTOMERS ABOUT THIS ISSUE ON JULY 28, 2015.

    Additional Manufacturer Narrative · 1

    CUSTOMER SENT ATTACHED DATA STREAM FILE WHICH WAS REVIEWED BY THE SIEMENS SOFTWARE TEAM AND IT WAS DETERMINED THAT A DUPLICATION WAS OCCURRING. THIS RP500 IS WORKING BY DUAL MODE. ->NETWORK PORT IS CONNECTING WITH RAPIDCOMM. ->SERIAL PORT IS CONNECTING WITH OTHER SYSTEM SINCE SOFTWARE V2.2, THE RP500 HAS DUAL PORT LIS TRANSMISSION CAPABILITY MEANING THE SYSTEM CAN BE CONNECTED TO 2 DATA MANAGEMENT SYSTEMS SUCH AS RAPIDCOMM AND ANOTHER DATA MANAGEMENT SYSTEM(DMS). THIS ALLOWS THE SYSTEM TO COMMUNICATE SIMULTANEOUSLY OVER THE SERIAL AND ETHERNET PORTS AND CONFIGURE EACH PORT TO SEND PATIENT, CALIBRATION, OR QC DATA. USER CAN SELECT WHICH DATA IS SENT OVER WHICH PORT AND CAN SPECIFY WHICH PORT SERVES AS THE PRIMARY INTERFACE. TYPICALLY A USER WOULD SETUP ONE PORT AS THE PRIMARY PORT WHICH WOULD INTERFACE WITH RCOMM OR A LIS AND SEND OUT ALL THE NECESSARY DATA. THEY WOULD THEN USE THE OTHER PORT TO JUST SEND OUT RESULTS, NOT HAVE IT SETUP TO ANY TYPE OF LIS. IN THIS COMPLAINT,THE CUSTOMER IS USING THIS DUAL TRANSMISSION FEATURE BUT BECAUSE THEY SETUP BOTH PORTS TO SEND OUT THE SAME TYPE OF INFORMATION, THE DATA IS GETTING DUPLICATED AND ONE PORT IS THEN OCCASIONALLY SENDING AN "INVALID' RESULTS MESSAGE. BASED ON THE INFORMATION AVAILABLE AT THE TIME COMPLAINT RECEIVED, SIEMENS DETERMINED THIS COMPLAINT NOT REPORTABLE TO FDA BECAUSE THERE WAS NO SAFETY ISSUE TO THE PATIENT OR OPERATOR. FURTHER INVESTIGATION ON THIS ISSUE REVEALED ADDITIONAL INFORMATION. 3. POTENTIAL FOR A RECORD FROM ONE SAMPLE DATA SET TO BE TRANSMITTED AS A RECORD ON A DIFFERENT SAMPLE DATA SET. HOWEVER, THIS SCENARIO HAS NOT BEEN OBSERVED BY CUSTOMERS AND SIEMENS HAS NOT BEEN ABLE TO REPRODUCE THIS SCENARIO IN-HOUSE AND IT IS EXTREMELY UNLIKELY TO OCCUR. BASED ON THE ADDITIONAL INFORMATION, SIEMENS MEDICAL AFFAIRS DETERMINED THIS ISSUE AS A LOW HEALTH RISK ON (B)(6) 2015. SIEMENS PERFORMED RETROSPECTIVE REVIEW OF ALL COMPLAINTS ASSOCIATED WITH THE ISSUE TO DETERMINE THEIR MEDICAL DEVICE REPORTING ELIGIBILITY. SIEMENS INVESTIGATED THE ISSUE AND HAS IDENTIFIED THE ROOT CAUSE; MITIGATIONS WILL BE IMPLEMENTED IN NEW SOFTWARE VERSION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT INVALID RESULTS MESSAGE SHOWED IN RCOMM (DATA MANAGEMENT SYSTEM) SINCE THEY INSTALLED SOFTWARE V2.2 UPGRADE. THERE WAS NO REPORT OF SERIOUS INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451026 RAPIDPOINT 500 RP 500 KHP SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1