BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT

    MDR report key: 12857936 · Received November 22, 2021

    Report

    Report Number
    1051575-2021-00001
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    November 2, 2021
    Report Date
    March 7, 2022
    Manufacturer
    STATCORP MEDICAL
    Product Code
    DXQ
    PMA / PMN Number
    K152801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER LATER CLARIFIED THAT THE REPORTED ISSUE WAS THAT THE CUFFS CAUSED DISCOMFORT TO THE PATIENT AND WOULD RESULT IN BRUISING OR SWELLING IN THE LOCATION OF THE CUFF. SWELLING AND BRUISING IS A KNOWN INHERENT RISK OF THE DEVICE AND DOES NOT REQUIRE SERIOUS MEDICAL INTERVENTION. SPACELABS HEALTHCARE HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER AND THE CUSTOMER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION ON THE EVENT. NO ADDITIONAL INFORMATION APPEARS TO BE FORTHCOMING AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21CFR 803.56. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 0

    SPACELABS HAS INITIATED AN INVESTIGATION INTO THIS MATTER. A SUPPLEMENTAL REPORT WILL BE FILED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SPACELABS WAS NOTIFIED THAT A PATIENT INJURY OCCURRED ON NOVEMBER 2, 2021. THE CUSTOMER REPORTED THAT A PATIENT RETURNED WITH A SWOLLEN ARM AND BRUISES AFTER WEARING A REUSABLE AMBULATORY BLOOD PRESSURE CUFF.

    Description of Event or Problem · 0

    SPACELABS RECEIVED A REPORT FROM THE CUSTOMER THAT A PATIENT INJURY OCCURRED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755929 ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT REUSABLE AMBULATORY BLOOD PRESSURE CUFF DXQ STATCORP MEDICAL 016-2635-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other