BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EARLYVUE VS30 VITALS MONITOR

    MDR report key: 11992367 · Received June 14, 2021

    Report

    Report Number
    1218950-2021-10643
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 31, 2021
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    DSJ
    UDI-DI
    00884838091412
    PMA / PMN Number
    K190624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS CREATED WITH REFERENCE TO MFG REPORT #1218950-2021-10643 WITH CORRECTED INFORMATION TO UPDATE THE MANUFACTURING SITE. H3 OTHER TEXT : NO ON SITE EVALUATION. ADDITIONAL INFORMATION UNAVAILABLE.

    Additional Manufacturer Narrative · 0

    IT WAS NOT KNOWN IF THE CUSTOMER IWASUSING THE CORRECT ROLL STAND PART NUMBER AS LISTED ON THE IFU. A CUSTOMER RESPONSE LETTER WAS SENT TO CONFIRM IF THE ROLL STAND PART NUMBER THAT CUSTOMER WAS USING IS THE CORRECT PART NUMBER PROVIDED IN THE VS30 INSTRUCTIONS FOR USE(IFU). IF ADDITIONAL INFORMATION IS LATER OBTAINED, THE COMPLAINT WILL BE REOPENED. H3 OTHER TEXT : NO ON SITE EVALUATION. ADDITIONAL INFORMATION UNAVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER IS HAVING PROBLEMS WITH THE SCREW THAT HOLDS THE VS30 TO THE CART AND ONE DEVICE FELL. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

    Description of Event or Problem · 0

    THE CUSTOMER IS HAVING PROBLEMS WITH THE SCREW THAT HOLDS THE VS30 TO THE CART AND ONE DEVICE FELL. THERE WAS NO REPORTED PATIENT IMPACT / INJURY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER IS HAVING PROBLEMS WITH THE SCREW THAT HOLDS THE VS30 TO THE CART AND ONE DEVICE FELL. PATIENT INVOLVEMENT IS UNKNOWN. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED BY THE CUSTOMER. THE EARLYVUE VS30 VITALS MONITOR (MODEL NUMBER 863359) IS SUBSTANTIALLY SIMILAR TO THE EARLYVUE VS30 VITALS MONITOR (MODEL NUMBER 863380) AND WILL BE REPORTED IN THE UNITED STATES UNDER DEVICE MODEL NUMBER 863380 (CFN/FEI # (B)(4); 510K K190624).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888823 EARLYVUE VS30 VITALS MONITOR EARLYVUE VS30 VITALS MONITOR DSJ PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 863380 00884838091412

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown