BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAGEWRITER TC 20 CARDIOGRAPH

    MDR report key: 11832588 · Received May 17, 2021

    Report

    Report Number
    1218950-2021-10547
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 19, 2021
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC
    Product Code
    DPS
    PMA / PMN Number
    K113144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REPAIR TECHNICIAN WAS SENT TO ASSIST THE CUSTOMER. A GOOD FAITH EFFORT WAS COMPLETED TO DETERMINE HOW THE UNIT FELL, BUT NO RESPONSE WAS RECEIVED. IT IS UNKNOWN HOW THE CUSTOMER'S ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE FRAME WAS DAMAGED FROM A FALL. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FRAME WAS DAMAGED FROM A FALL. NO OTHER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. THE PAGEWRITER TC10 CARDIOGRAPH (MODEL NUMBER 860392) IS SUBSTANTIALLY SIMILAR TO THE PAGEWRITER TC20 CARDIOGRAPH (MODEL NUMBER 860332) AND WILL BE REPORTED IN THE UNITED STATES UNDER DEVICE MODEL NUMBER 860332 (CFN/FEI # (B)(4); 510K K113144).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728496 PAGEWRITER TC 20 CARDIOGRAPH PAGEWRITER TC 20 CARDIOGRAPH DPS PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC 860332

    Patients

    Seq Age Sex Outcome Treatment
    1