BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSM-2351A

    MDR report key: 8642648 · Received May 24, 2019

    Report

    Report Number
    8030229-2019-00174
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    May 3, 2019
    Report Date
    August 13, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K011918
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL NARRATIVE: ON (B)(6) 2019, CUSTOMER REPORTED THE BEDSIDE MONITOR (BSM-2351A SN: (B)(6) WAS GIVING ERRATIC READINGS AND WOULD DROP IN AND OUT. THIS WAS TESTED ON A SIMULATOR WITH NEW TRUNK CABLE AND LEAD SETS. THE UNIT WOULD WORK FOR A FEW MINUTES BUT THEN STARTED TO GIVE ERRATIC READINGS AND COME IN AND OUT. CUSTOMER DID NOT THINK THE ECG SOCKET WAS LOOSE. SERVICE REQUESTED: TROUBLESHOOTING/EXCHANGE. SERVICE PERFORMED: CUSTOMER WAS ADVISED THE DEVICE WAS OEL AND NKA NO LONGER SERVICES THEM. CUSTOMER DID NOT FEEL COMFORTABLE DOING THE REPAIRS THEMSELVES AND UNDERSTOOD THEY WOULD HAVE TO PURCHASE NEW EQUIPMENT FROM THEIR SALES REPRESENTATIVE. INVESTIGATION RESULT: THE BSM WARRANTY BEGAN 08/19/2007, WHICH IS OVER 11.5 YEARS PRIOR TO THE REPORTED ISSUE. A REVIEW OF DEVICE HISTORY FOUND NO PREVIOUSLY REPORTED ISSUES WITH THE UNIT. THE UNIT WAS NOT RETURNED AND NO NKA EVALUATION WAS PERFORMED. THE REPORTED ISSUE WAS NOT CONFIRMED. INFORMATION ON THE CONDITION OF THE UNIT IS NOT AVAILABLE. PER BSM-2300A SERIES SERVICE MANUAL, A MAINTENANCE CHECK SHOULD BE PERFORMED ONCE EVERY SIX MONTHS. A MAINTENANCE CHECK SHEET IS INCLUDED IN THE SERVICE MANUAL, WHICH INCLUDES CHECKING THE VITAL SIGN PARAMETERS. CUSTOMER'S MAINTENANCE INFORMATION FOR THIS UNIT IS NOT AVAILABLE. THERE IS NO SAP RECORD OF NKA SERVICING PERFORMED ON THIS UNIT. THE BSM-2351A MODEL WAS DISCONTINUED ON 08/03/2011 IN MBG-110308A DUE TO THE INTRODUCTION OF THE BSM-6000 SERIES MONITOR. SUPPORT FOR THE UNIT CONTINUED FOR A MINIMUM PERIOD OF SEVEN YEARS. THE ISSUE OCCURRED WELL BEYOND THE WARRANTY AND SUPPORT PERIOD. DUE TO THE AGE OF THE UNIT, POSSIBLE ROOT CAUSE IS MAINTENANCE NEEDED. THIS ISSUE IS NOT SUSPECTED TO BE CAUSED BY DEFICIENT DESIGN. CORRECTION: D4. SERIAL #. INCORRECT SERIAL # LISTED ON MDR INITIAL REPORT. CORRECTED ON MDR FOLLOW UP REPORT 001. F9. APPROXIMATE AGE OF DEVICE. AGE OF DEVICE INCORRECTLY CALCULATED BASED ON INCORRECT SERIAL # AND MANUFACTURER DATE. CORRECTED ON MDR FOLLOW UP REPORT 001. H4. DEVICE MANUFACTURE DATE: BASED ON INCORRECT SERIAL #. CORRECTED ON MDR FOLLOW UP REPORT 001. ADDITIONAL INFORMATION: B4. DATE OF THIS REPORT. F6. DATE USER FACILITY/IMPORTER BECAME AWARE OF THE EVENT. F7. TYPE OF REPORT. F11. DATE REPORT SENT TO FDA. F13. DATE REPORT SENT TO MANUFACTURER. G4. DATE RECEIVED BY MANUFACTURER. G7. TYPE OF REPORT. H2. IF FOLLOW-UP, WHAT TYPE? ADDITIONAL INFORMATION. H6. EVENT PROBLEM AND EVALUATION CODES. H10. ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE BSM (BEDSIDE MONITOR) IS GIVING ERRATIC READINGS AND WILL DROP IN AND OUT. NO PATIENT HARM OR INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE BSM (BEDSIDE MONITOR) IS GIVING ERRATIC READINGS AND WILL DROP IN AND OUT. NO PATIENT HARM OR INJURY WAS REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BSM (BEDSIDE MONITOR) IS GIVING ERRATIC READINGS AND WILL DROP IN AND OUT. NO PATIENT HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435556 BSM-2351A VITAL SIGNS MONITOR MHX NIHON KOHDEN CORPORATION BSM-2351A NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1