BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN

    MDR report key: 12566557 · Received October 3, 2021

    Report

    Report Number
    3013095415-2021-00423
    Event Type
    Malfunction
    Date Received
    October 3, 2021
    Date of Event
    May 28, 2021
    Report Date
    September 27, 2021
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007945
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 002 ¿ SECTION H2, IF FOLLOW-UP, WHAT TYPE? OF SUPPLEMENTAL MEDWATCH REPORT 001 STATED: CORRECTION & DEVICE EVALUATION SECTION H2, IF FOLLOW-UP, WHAT TYPE? OF SUPPLEMENTAL MEDWATCH REPORT 001 SHOULD HAVE STATED: CORRECTION & ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 001 -- SECTION D4, MODEL #, OF THE INITIAL MEDWATCH REPORT STATED: PRT-01201-000 SECTION D4, MODEL #, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: V+PRO EMERGENCY, ENGLISH SECTION D4, EXPIRATION DATE, OF THE INITIAL MEDWATCH REPORT STATED: BLANK SECTION D4, EXPIRATION DATE, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: 06/13/2022 SECTION D4, UDI #, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION D4, UDI #, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(6). NEW INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 001 -- H6: THE INITIAL REPORTER WAS ADVISED TO CONTACT THE AGENCY MANAGING THE GOVERNMENT STOCKPILE TO BEGIN THE RMA (RETURN MERCHANDISE AUTHORIZATION) PROCESS. THE REPORTER ADVISED VENTEC THAT HE WOULD CONTACT HIS REPRESENTATIVE AT THE AGENCY FOR ASSISTANCE. THE DEVICE HAS NOT BEEN RETURNED TO VENTEC FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    VENTEC WILL PERFORM AN EVALUATION OF THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56. THIS MDR HAS BEEN REASSESSED AS REPORTABLE AFTER CONDUCTING A RETROSPECTIVE REVIEW OF PRIOR COMPLAINT RECORDS. AS THIS HAS BEEN REASSESSED, IT WILL APPEAR TO BE A LATE MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VENTEC THAT THE TOUCHSCREEN ON THE DEVICE WAS UNRESPONSIVE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464131 VOCSN VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC V+PRO EMERGENCY, ENGLISH 00855573007945

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown