BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GZ-120PA

    MDR report key: 7438727 · Received April 17, 2018

    Report

    Report Number
    8030229-2018-00331
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    July 23, 2018
    Report Date
    January 24, 2020
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRT
    UDI-DI
    04931921117392
    PMA / PMN Number
    K153707
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA EVENT PROBLEM AND EVALUATION CODES. ADDITIONAL MANUFACTURER NARRATIVE. ADDITIONAL INFORMATION: FOLLOW UP. ADDITIONAL INFORMATION/CORRECTION. FIELD REQUIRED FOR SUBMISSION. ADDITIONAL MANUFACTURER NARRATIVE: THE CUSTOMER REPORTED THAT THE PATIENT SHOULD HAVE ALARMED V-FIB, THE NURSES REPORTED THAT BOTH THE BEDSIDE MONITOR (BSM) AND THE CENTRAL NURSE'S STATION (CNS) DID NOT ALARM. THE CUSTOMER SENT AN EMAIL CONTAINING PICTURES OF THE REQUESTED PATIENT INFORMATION BY THE CLINICAL TEAM. KELLY REVIEWED THE PICTURES AND COULD SEE V-FIB AND TACHYCARDIA BUT THE UNIT DID NOT ALARM. THE ISSUE WAS ESCALATED TO THE QA TEAM WHERE IT WAS CONFIRMED THAT THE UNIT FAILED TO ALARM. THREE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER WITH NO RESPONSE.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON 7/23/2018 CUSTOMER STATED THAT THE GAS UNIT DID NOT GIVE CO2 WAVEFORM. DEVICE WAS SENT TO NKA FOR EVALUATION AND REPAIR. ON 9/17/2018 NKA REPAIR CENTER EVALUATED THE DEVICE. DEVICE DISPLAYED "GAS DEVICE ERROR". THIS WAS DIAGNOSED AS SENSOR UNIT CD-314P-01 ON 1/16/2020 NKA REPAIR CENTER RE-EVALUATED THE DEVICE. THE SAME OBSERVATION WAS NOTED. SERVICE REQUESTED: EVALUATION AND REPAIR. SERVICE PERFORMED: EVALUATION. INVESTIGATION RESULT: DEVICE WAS PUT INTO SERVICE 5/28/2015. SERVICE HISTORY FOR THIS DEVICE SHOWS THE FOLLOWING: 07/23/2018 300132516 - REPORTED THE SAME DAY AS THE CURRENT NOTIFICATION. CUSTOMER STATED USER PULLED THE CABLE HARD ENOUGH TO BREAK IT APART. 07/23/2018 300132506 - CURRENT NOTIFICATION. INFORMATION NECESSARY FOR INVESTIGATION WAS NOT AVAILABLE, SPECIFICALLY: WATER TRAP REPLACEMENT FREQUENCY GAS SETTINGS ON BEDSIDE MONITOR. FOR EXAMPLE, IF THE SCREEN LAYOUT ON THE BEDSIDE MONITOR IS SET TO FIXED MODE, ARE THE PARAMETER SETTINGS PROPERLY CONFIGURED? VERIFICATION OF PROPER CONNECTION FOR THE WATER TRAP AND SAMPLING LINE ARE THE GAS UNITS POSITIONED AT A PERMANENT LOCATION OR FREQUENTLY MOVED? IF FREQUENTLY MOVED, IS THE MULTI-LINK CONNECTION CABLE NEXT TO THE GROUNDING TERMINAL SECURELY SEATED WITH TWO SCREWS TIGHTENED? ARE THERE ANY BENTS ON THE EXHAUST GAS TUBE? DOES THE BACTERIAL FILTER, WHERE THE EXHAUST TUBE IS CONNECTED TO, CONFORM TO 0.2 MICROMETER PORE SIZE? ARE THE UNITS STORED IN HIGH HUMIDITY LOCATIONS? IS THERE ADEQUATE SPACE BEHIND THE UNIT FOR THE FAN TO OPERATE PROPERLY? ARE THERE ANY UNITS PLACED VERTICALLY? IF SO, DID CUSTOMER ORIENTATE THE WATER TRAP ACCORDING TO MANUAL'S INSTRUCTION? SERVICE MANUAL FOR GF-210R/220R, SECOND EDITION, PRINTED 2012/09/21 INCLUDES THE FOLLOWING SELECTED ITEMS: GENERAL HANDLING PRECAUTIONS: INSTRUMENT MUST RECEIVE EXPERT, PROFESSIONAL ATTENTION FOR MAINTENANCE AND REPAIRS. WHEN THE INSTRUMENT IS NOT FUNCTIONING PROPERLY, IT SHOULD BE CLEARLY MARKED TO AVOID OPERATION WHILE IT IS OUT OF ORDER. INSTRUMENT AND PARTS MUST UNDERGO REGULAR MAINTENANCE INSPECTION AT LEAST EVERY 6 MONTHS. IF STORED FOR EXTENDED PERIODS WITHOUT BEING USED, MAKE SURE PRIOR TO OPERATION THAT THE INSTRUMENT IS IN PERFECT OPERATING CONDITION. PER SERVICE MANUAL, REGULAR MAINTENANCE AND INSPECTION MUST BE PERFORMED EVERY SIX MONTHS. THE "GAS DEVICE ERROR" WAS ATTRIBUTED TO SENSOR UNIT CD-314P-01 FAILURE. THIS REPAIR COULD NOT BE PERFORMED AT NKA. WITH LITTLE INFORMATION PROVIDED REGARDING CUSTOMER'S MAINTENANCE OF THE DEVICE, THE ROOT CAUSE OF THE SENSOR FAILURE COULD NOT BE DETERMINED. A REVIEW OF MANUFACTURER'S DEVICE HISTORY RECORD SHOWS NO NONCONFORMING REPORT, NO DEVIATION AND NO CORRECTIVE AND PREVENTATIVE ACTIONS ASSOCIATED WITH THIS DEVICE. INVESTIGATION CONCLUSION: THE "GAS DEVICE ERROR" WAS ATTRIBUTED TO SENSOR UNIT CD-314P-01 FAILURE. THIS REPAIR COULD NOT BE PERFORMED AT NKA. WITH LITTLE INFORMATION PROVIDED REGARDING CUSTOMER'S MAINTENANCE OF THE DEVICE, THE ROOT CAUSE OF THE SENSOR FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE GAS UNIT IS NOT GETTING A WAVEFORM FOR THE CO2 GAS. CUSTOMER WOULD LIKE TO SEND THE UNIT IN FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GAS UNIT IS NOT GETTING A WAVEFORM FOR THE CO2 GAS. CUSTOMER WOULD LIKE TO SEND THE UNIT IN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281689 GZ-120PA TRANSMITTER DRT NIHON KOHDEN CORPORATION GZ-120PA NOT APPLICABLE 04931921117392

    Patients

    Seq Age Sex Outcome Treatment
    1