BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-520PA

    MDR report key: 8198083 · Received December 26, 2018

    Report

    Report Number
    8030229-2018-00495
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    December 4, 2018
    Report Date
    July 22, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL NARRATIVE: DETAILS OF COMPLAINT: ON (B)(6) 2018, CUSTOMER STATED TRANSMITTER WAS GIVING SIGNAL LOSS ERROR MESSAGE. CUSTOMER REQUESTED REPAIR SERVICES. SERVICE REQUESTED: REPAIR. SERVICE PERFORMED: REPAIR. INVESTIGATION RESULT: NKA REPAIR CENTER REPLACED THE FOLLOWING PARTS TO RESOLVE THE ISSUE: CD-323P CENTER CASE ASSEMBLY. 110168 O-RING. 6114918572A CASE SEALANT. DEVICE WAS DELIVERED TO CUSTOMER ON (B)(6) 2018. SERVICE HISTORY FOR THIS DEVICE SHOWS NO OTHER SERVICE NOTIFICATIONS. SERVICE HISTORY FOR THIS CUSTOMER SHOWS THREE ADDITIONAL INCIDENTS AROUND THE SAME TIME: 48641: REPORTED ON (B)(6) 2019. CUSTOMER WAS COMPLAINING OF NOISY SIGNAL. NKA REPAIR CENTER EVALUATED THE DEVICE. THE REPORTED ISSUE COULD NOT BE DUPLICATED. 48642: REPORTED ON (B)(6) 2019. CUSTOMER WAS COMPLAINING OF NOISY SIGNAL. PHYSICALLY DAMAGED PARTS WERE REPLACED: SCREEN, SELECT KEY, FRONT CASE ASSEMBLY, CENTER CASE ASSEMBLY. 48821: REPORTED ON (B)(6) 2019. ORG RECEIVER WAS REPORTED TO BE CAUSING SIGNAL LOSS. THE ROOT CAUSE WAS DUE TO DEVICE NOT HAVING POWER. THE ABOVE HISTORY SHOWS THERE WERE TWO INCIDENTS OF ZM TRANSMITTERS SUFFERING FROM SIGNAL ISSUES DUE RELATING TO DAMAGES TO THE CENTER CASE ASSEMBLY. THE ISSUE WAS RESOLVED ONCE THE CENTER CASE ASSEMBLY WAS REPLACED. THE ROOT CAUSE OF THE REPORTED ISSUE HERE WAS DUE TO PHYSICAL DAMAGES. A REVIEW OF MANUFACTURER'S DEVICE HISTORY RECORD SHOWS NO NONCONFORMING REPORT, NO DEVIATION AND NO CORRECTIVE AND PREVENTATIVE ACTIONS ASSOCIATED WITH THIS DEVICE. PLEASE SEE ATTACHED DHR REVIEW FORM. CORRECTED INFORMATION: F9. APPROXIMATE AGE OF DEVICE: INCORRECTLY CALCULATED. 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. CORRECTION. DEVICE EVALUATION. H6. EVENT PROBLEM AND EVALUATION CODES. H10. ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED SIGNAL LOSS ON MULTIPLE CHANNELS. NO CONSEQUENCE OR IMPACT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED SIGNAL LOSS ON MULTIPLE CHANNELS. NO CONSEQUENCE OR IMPACT TO THE PATIENT WAS REPORTED. THE REPORTED DEVICE WAS RETURNED AND EVALUATED. DURING EVALUATION, THE REPORTED COMPLAINT OF SIGNAL LOSS" WAS DUPLICATED. ALL MALFUNCTIONING PARTS WERE REPLACED. THE UNIT WAS TESTED PER THE OPERATOR'S MANUAL - SERVICE MANUAL. THE UNIT COMPLETED 24 HOURS OF EXTENDED TESTING AND OPERATES TO MANUFACTURER'S SPECIFICATIONS. THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED SIGNAL LOSS ON MULTIPLE CHANNELS. NO CONSEQUENCE OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035505 ZM-520PA TRANSMITTER DRT NIHON KOHDEN CORPORATION ZM-520PA NOT APPLICABLE 04931921115077

    Patients

    Seq Age Sex Outcome Treatment
    1