BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS MODEL 90217 ABP MONITOR

    MDR report key: 5089244 · Received September 18, 2015

    Report

    Report Number
    9611295-2015-00015
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    April 29, 2015
    Report Date
    May 28, 2020
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    DXN
    PMA / PMN Number
    K103732
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS TESTED BY A SPACELABS REGIONAL CUSTOMER SUPPORT AND THE EQUIPMENT PERFORMED TO SPECIFICATIONS. THE AVAILABLE EVIDENCE INDICATES THAT THE PATIENT OCCLUDED THE HOSE IN HIS SLEEP WHICH PREVENTED DEFLATION. SPACELABS REGIONAL CUSTOMER SUPPORT HAS ADVISED THE CUSTOMER APPROPRIATELY. OPS MANUAL (B)(6) 070-2340-00 REV C, PG. 1-15 HAS A SPECIFIC WARNING TO AVOID COMPRESSION OR RESTRICTION OF THE HOSE. THERE WAS NO SPACELABS PRODUCT MALFUNCTION. THIS REPORT IS FINAL AND THE ISSUE IS CLOSED. THIS REPORT IS BEING GENERATED AT THE DIRECTION OF FDA BECAUSE OF SUPPLEMENTAL REPORTS RECEIVED, WITH THIS MANUFACTURER REPORT NUMBER, AND NO RECORD OF AN INITIAL REPORT.  THIS MANUFACTURER REPORT IS SUBMITTED TO CORRECT A PREVIOUS REPORT, 3010157426-2014-00109, THAT MISTAKENLY IDENTIFIED THE MANUFACTURER REPORT NUMBER; AT FDA FORM 3500A TOP OF PAGE 1 AND SECTION G(9) AND MISTAKENLY IDENTIFIED THE MANUFACTURER IN SECTION D(3) BY LISTING THE MANUFACTURE¿S AFFILIATE ENTITY.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT ON APRIL 29, 2015, THAT A HOME STUDY PATIENT IN (B)(6) EXPERIENCED INJURY FROM WEARING THE SPACELABS AMBULATORY BLOOD PRESSURE MONITOR, WHICH IS MANUFACTURED IN THE UNITED STATES. WHILE THE PATIENT WAS TAKING AN AFTERNOON NAP, THE MONITOR INFLATED THE BLOOD PRESSURE CUFF, AND THE CUFF STAYED INFLATED FOR AN UNKNOWN AMOUNT OF TIME CAUSING THE PATIENT¿S ARM TO BECOME SWOLLEN. THE PATIENT WAS TAKEN TO THE LOCAL EMERGENCY ROOM WHERE CREAM, AND COLD TOWELS WERE APPLIED TO HIS SWOLLEN ARM. NO OTHER TREATMENT WAS REQUIRED, AND THERE WAS NO REPORTED PROLONGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620655 SPACELABS MODEL 90217 ABP MONITOR ABP MONITOR DXN SPACELABS HEALTHCARE LTD. 90217

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male