BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACHECK SPACELABS ABP CUFFS

    MDR report key: 6370424 · Received March 1, 2017

    Report

    Report Number
    3010157426-2017-00021
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    January 30, 2017
    Report Date
    March 15, 2017
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DXQ
    PMA / PMN Number
    K152801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT RECEIVED TREATMENT FOR TOURNIQUET SYNDROME, HOWEVER, THE INJURY IS INCONSISTENT WITH THE DEVICE USE CONSIDERING THE RECORDED AUTOMATIC BLOOD PRESSURE READINGS FOR THE PATIENT. DESPITE REPEATED ATTEMPTS, NO FURTHER INFORMATION COULD BE OBTAINED REGARDING PATIENT ACTIVITY WHILE WEARING THE DEVICE, OR ANY PATIENT COMORBIDITIES. THE BLOOD PRESSURE CUFF WAS RETURNED, AND FINDINGS SHOW NO EVIDENCE OF DEVICE MALFUNCTION, HOWEVER A REPLACEMENT WAS SENT OUT OF AN ABUNDANCE OF CAUTION. THE ASSOCIATED BLOOD PRESSURE PUMP WAS ALSO RECEIVED FOR SERVICE AND FINDINGS INDICATE THAT THERE WAS NO MALFUNCTION WITH THE PUMP FUNCTION. THIS REPORT IS CONSIDERED COMPLETE AND THIS PARTICULAR ISSUE CLOSED.

    Additional Manufacturer Narrative · 1

    SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT ON (B)(6), 2017 THAT A PATIENT IN (B)(6), WAS WEARING A SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF AND DEVELOPED A SWOLLEN FOREARM WITH HEMATOMA, AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149881 ULTRACHECK SPACELABS ABP CUFFS BLOOD PRESSURE CUFF DXQ SPACELABS HEALTHCARE INC. 016-2635-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other