BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSM

    MDR report key: 9169768 · Received October 8, 2019

    Report

    Report Number
    8030229-2019-00555
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 13, 2019
    Report Date
    March 2, 2020
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON (B)(6) 2019 CUSTOMER STATED THAT THE NIBP FUNCTION OF AY-653P-QA WAS EXPERIENCING AN ISSUE - THE PUMP DOES NOT DEFLATE ONCE IT HAS BEEN FULLY INFLATED. DEVICE WAS SENT TO NKA FOR EVALUATION AND REPAIR. NKA REPAIR CENTER EVALUATED THE DEVICE. THE REPORTED ISSUE WAS OBSERVED. THE FOLLOWING PARTS 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 THE AY-653P INPUT UNIT WAS ATTACHED TO A MAIN BEDSIDE MONITOR (BSM) AND WAS RETURNED FOR REPAIR WITHOUT THE MAIN BSM UNIT. THIS ISSUE WAS FOUND AT SETUP, NOT WHILE IN PATIENT USE. INVESTIGATION CONCLUSION: THE NIBP PUMP FAILURE ISSUE WAS INVESTIGATED UNDER IRC-NKA300083020 (ATTACHED) AND CLOSED IN 10/16/2017. THE CAUSE OF PUMP FAILURE WAS DETERMINED TO BE CRACKED DIAPHRAGM DUE TO NEGATIVE PRESSURE AT THE DIAPHRAGM. THIS IS IN TURN CAUSED BY THE INTAKE PORT BLOCKAGE PREVENTING NORMAL PUMP OPERATION. THE BLOCKAGE COULD BE OF ANY TRIGGER SUCH AS DIRT ACCUMULATION AT THE VALVE. IN SUCH CASES, THE PUMP IS RECOMMENDED TO BE REPLACED. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THIS REPORT: D1 BRAND NAME: LISTED AS BSM AS THE BRAND NAME WAS NOT PROVIDED. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE FOR THE MAIN BSM UNIT, BUT NOT PROVIDED: D4: MODEL NUMBER CATALOG NUMBER SERIAL NUMBER UDI NUMBER F9 APPROXIMATE AGE OF DEVICE G5 PMA/510(K) NUMBER H4 DEVICE MANUFACTURE DATE ADDITIONAL DEVICE INFORMATION: D11 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE MAIN BSM AND IS THE DEVICE THAT EXPERIENCED THE FAILURE: INPUT UNIT MODEL: AY-653P SN: (B)(6) UDI NUMBER: (B)(4) MANUFACTURED DATE: 08/09/2013 AGE OF THE DEVICE: 73 MONTHS RETURNED TO NK: 09/27/2019 CORRECTIONS H3. DEVICE EVALUATED BY MANUFACTURER OTHER - DEVICE WAS NOT RETURNED WAS REVISED TO OTHER - SEE H10

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NON-INVASIVE BLOOD PRESSURE (NIBP) PUMP, ATTACHED TO THE AY-653P INPUT UNIT, WOULD NOT DEFLATE ONCE IT HAD BEEN FULLY INFLATED. THE AY-653P INPUT UNIT WAS ATTACHED TO A MAIN BEDSIDE MONITOR (BSM) AND WAS RETURNED FOR REPAIR WITHOUT THE MAIN BSM. THIS ISSUE WAS FOUND AT SETUP, NOT WHILE IN PATIENT USE.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NON-INVASIVE BLOOD PRESSURE (NIBP) PUMP, ATTACHED TO THE AY-653P INPUT UNIT, WOULD NOT DEFLATE ONCE IT HAD BEEN FULLY INFLATED. THE AY-653P INPUT UNIT WAS ATTACHED TO A MAIN BEDSIDE MONITOR (BSM) AND WAS RETURNED FOR REPAIR WITHOUT THE MAIN BSM. THIS ISSUE WAS FOUND AT SETUP, NOT WHILE IN PATIENT USE. IHON 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. BRAND NAME: LISTED AS BSM AS THE BRAND NAME WAS NOT PROVIDED. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE MAIN BSM AND IS THE DEVICE THAT EXPERIENCED THE FAILURE: INPUT UNIT, MODEL: AY-653P, SN:(B)(4), UDI NUMBER: (B)(4), MANUFACTURED DATE: 08/09/2013, AGE OF THE DEVICE: 73 MONTHS, RETURNED TO NK: 09/27/2019.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NON-INVASIVE BLOOD PRESSURE (NIBP) PUMP, ATTACHED TO THE AY-653P INPUT UNIT, WOULD NOT DEFLATE ONCE IT HAD BEEN FULLY INFLATED. THE AY-653P INPUT UNIT WAS ATTACHED TO A MAIN BEDSIDE MONITOR (BSM) AND WAS RETURNED FOR REPAIR WITHOUT THE MAIN BSM. THIS ISSUE WAS FOUND AT SETUP, NOT WHILE IN PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960211 BSM VITAL SIGNS MONITOR MHX NIHON KOHDEN CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 AY-653P SN (B)(6)| AY-653P SN (B)(6)