BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSM-6301A

    MDR report key: 9399138 · Received December 2, 2019

    Report

    Report Number
    8030229-2019-00697
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 6, 2019
    Report Date
    April 20, 2020
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921103517
    PMA / PMN Number
    K080342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON (B)(6) 2019 CUSTOMER STATED INPUT UNIT (AY-671P-A0 S/N (B)(6) ) WAS EXPERIENCING INPUT MODULE FAILURE. BLOOD PRESSURE READINGS HAVE BEEN HIGHER THAN EXPECTED. WHEN CUSTOMER SWAPPED OUT INPUT UNIT WITH ANOTHER (MODEL AND S/N NOT PROVIDED), THE ISSUES WERE RESOLVED. THE MAIN BSM WAS NOT RETURNED, BUT THE AY-671P INPUT UNIT WAS. DEVICE WAS SENT TO NKA FOR EVALUATION AND REPAIR. NKA REPAIR CENTER CONFIRMED THE REPORTED ISSUE. THE FOLLOWING COMPONENTS WERE REPLACED TO RESOLVE THE ISSUE: 1-PART# 532149B DESCRIPTION: PUMP QTY:1 2- PART # 6114135418 DESCRIPTION: VIBRATION DAMPING SPONGE QTY: 1 3- PART # 923119 DESCRIPTION: SOLENOID VALVE QTY:1. INVESTIGATION CONCLUSION: AS THE RISK WAS ASSESSED TO BE LOW, AND WHERE THE PUMP FUNCTIONALITY IS A REGULAR INSPECTION ITEM AND IS REPLACEABLE, NO CAPA IS REQUIRED. THIS ISSUE IS RECOMMENDED TO BE TRACKED AND TRENDED. ADDITIONAL DEVICE INFORMATION: D11 & C2 CONCOMITANT MEDICAL DEVICE. THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE MAIN BSM UNIT AND WAS THE UNIT THAT FAILED: AY-671P SN (B)(6) INPUT UNIT: THE UDI NO: (B)(4). MANUFACTURED DATE: 11/13/2009. AGE OF THE DEVICE: 119 MONTHS. RETURNED TO NK: YES, 11/21/2019.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTS THAT THE BLOOD PRESSURE (BP) READINGS HAVE BEEN OFF FOR THREE DAYS. BP IS HIGHER THAN WHAT THEY SHOULD BE ON THE BEDSIDE MONITOR (BSM). ISSUE WAS RESOLVED BY REPLACING THE AY INPUT MODULE WHICH IS PART OF THE BSM SYSTEM WITH ANOTHER WORKING UNIT. NO PATIENT HARM REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTS THAT THE BLOOD PRESSURE (BP) READINGS HAVE BEEN OFF FOR THREE DAYS. BP IS HIGHER THAN WHAT THEY SHOULD BE ON THE BEDSIDE MONITOR (BSM). ISSUE WAS RESOLVED BY REPLACING THE AY INPUT MODULE WHICH IS PART OF THE BSM SYSTEM WITH ANOTHER WORKING UNIT. THE MAIN BSM WAS NOT RETURNED, BUT THE AY-671P INPUT UNIT WAS. NO PATIENT HARM REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR PART 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. CONCOMITANT MEDICAL DEVICE. THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE MAIN BSM UNIT AND WAS THE UNIT THAT FAILED: AY-671P SN: (B)(4). INPUT UNIT: THE UDI NO: (B)(4). MANUFACTURED DATE: 11/13/2009. AGE OF THE DEVICE: 119 MONTHS. RETURNED TO NK: YES, 11/21/2019.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTS THAT THE BLOOD PRESSURE (BP) READINGS HAVE BEEN OFF FOR THREE DAYS. BP IS HIGHER THAN WHAT THEY SHOULD BE ON THE BEDSIDE MONITOR (BSM). ISSUE WAS RESOLVED BY REPLACING THE AY INPUT MODULE WHICH IS PART OF THE BSM SYSTEM WITH ANOTHER WORKING UNIT. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190560 BSM-6301A VITAL SIGNS MONITOR MHX NIHON KOHDEN CORPORATION BSM-6301A NA 04931921103517

    Patients

    Seq Age Sex Outcome Treatment
    1 AY-671P SN (B)(6) | AY-671P SN (B)(6)