BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-520PA

    MDR report key: 7803709 · Received August 21, 2018

    Report

    Report Number
    8030229-2018-00327
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    July 22, 2018
    Report Date
    August 28, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRT
    UDI-DI
    04931921115077
    PMA / PMN Number
    K043517
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT: CUSTOMER REPORTED A TRANSMITTER (ZM-520PA) WAS UNABLE TO TRANSFER TO A BEDSIDE WHEN MOVING A PATIENT. THE TRANSMITTER WENT BLANK. THE PATIENT WAS MOVED TO THE BEDSIDE MONITOR MANUALLY AND THE TRANSMITTER WAS TAKEN OUT OF SERVICE. SERVICE REQUESTED: TROUBLESHOOTING/ASSISTANCE SERVICE PERFORMED: CUSTOMER ENDED THE CALL BECAUSE IT WAS TAKING TOO LONG TO TROUBLESHOOT. MULTIPLE FOLLOW UPS WERE ATTEMPTED BUT NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED. MISSING INFORMATION/REQUIRED INFORMATION: THE DEVICE INFORMATION ASSOCIATED WITH THE COMPLAINT FILE IS NOT ENTERED IN THE "PRODUCT" FIELD. THIS IS A KNOWN ISSUE AND IS ADDRESSED IN CAPA 18-033. INVESTIGATION OF THE COMPLAINT WILL CONTINUE WITHOUT THE PRODUCT INFORMATION. INVESTIGATION RESULT: THE DEVICE WAS IN USE WITH A PATIENT AND THERE WAS NO REPORTED HARM. AS THE DEVICE WAS NOT RETURNED, EVALUATION OF THE UNIT COULD NOT BE PERFORMED. AS THE DEVICE INFORMATION WAS NOT PROVIDED, DEVICE HISTORY CANNOT BE REVIEWED. DUE TO THE LACK OF INFORMATION AVAILABLE, THE ROOT CAUSE IS UNABLE TO BE DETERMINED. FURTHER INVESTIGATION IS NOT POSSIBLE WITHOUT ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL NARRATIVE: ON (B)(6) 2018, (B)(6) AT (B)(6) HOSPITAL REPORTED A TRANSMITTER (ZM-520PA SN: ?) WAS UNABLE TO TRANSFER TO A BEDSIDE [MONITOR] WHEN THEY WERE MOVING A PATIENT. THE TRANSMITTER WENT BLANK. THE PATIENT WAS MOVED TO THE BEDSIDE MONITOR MANUALLY AND THE TRANSMITTER WAS TAKEN OUT OF SERVICE. SERVICE REQUESTED TROUBLESHOOTING/ASSISTANCE. SERVICE PERFORMED: CUSTOMER ENDED THE CALL BECAUSE IT WAS TAKING TOO LONG TO TROUBLESHOOT. MULTIPLE FOLLOW UPS WERE ATTEMPTED BUT NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED. MISSING INFORMATION/REQUIRED INFORMATION: THE DEVICE INFORMATION ASSOCIATED WITH THE COMPLAINT FILE IS NOT ENTERED IN THE "PRODUCT" FIELD. INVESTIGATION RESULT: REVIEW OF TICKETS OPENED AT THE FACILITY AROUND THE TIME OF REPORTED ISSUE FOUND NO OTHER RELATED TICKETS OPENED. REVIEW OF SIMILAR TICKETS USING KEYWORDS "ZM-520PA DROP/TRANSFER/BLANK" FOUND NO RELEVANT TICKETS REPORTED AT OTHER FACILITIES. DUE TO THE LACK OF INFORMATION AVAILABLE, THE ROOT CAUSE IS UNABLE TO BE DETERMINED. NO ADVERSE TREND SUSPECTED FOR THIS ISSUE. ADDITIONAL INFORMATION: B4. DATE OF THIS REPORT. D11. CONCOMITANT MEDICAL PRODUCTS. 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. H3. DEVICE EVALUATED BY MANUFACTURER? H6. EVENT PROBLEM AND EVALUATION CODES. H10. ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE TRANSMITTER DROPPED TRANSMISSION OF THE PATIENT'S VITAL SIGNS WHILE ATTEMPTING A PATIENT TRANSFER BACK TO THE BEDSIDE. THE TRANSMITTER'S DISPLAY ALSO WENT BLANK.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS MANUALLY TRANSFERRED TO THE BEDSIDE AND THE FAILED TRANSMITTER WAS REMOVED FROM SERVICE. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED AFTER 3 FOLLOW-UP ATTEMPTS TO FIND OUT THE DISPOSITION OF THE DEVICE, THE SERIAL NUMBER OF THE DEVICE, OR ANY ADDITIONAL INFORMATION REGARDING THE OUTCOME OF THE EVENT. NO PATIENT HARM 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 TRANSMITTER DROPPED TRANSMISSION OF THE PATIENT'S VITAL SIGNS WHILE ATTEMPTING A PATIENT TRANSFER BACK TO THE BEDSIDE. THE TRANSMITTER'S DISPLAY ALSO WENT BLANK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643312 ZM-520PA TRANSMITTER DRT NIHON KOHDEN CORPORATION ZM-520PA NOT APPLICABLE 04931921115077

    Patients

    Seq Age Sex Outcome Treatment
    1 BEDSIDE MONITOR