BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF

    MDR report key: 4552456 · Received February 26, 2015

    Report

    Report Number
    3010157426-2015-00030
    Event Type
    Injury
    Date Received
    February 26, 2015
    Date of Event
    April 17, 2014
    Report Date
    February 26, 2015
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S SKIN CONDITION WAS SUCCESSFULLY TREATED WITH BIAFINE CREAM PRESCRIBED BY THE ATTENDING PHYSICIAN. ONSITE TESTING OF THE INVOLVED DEVICE BY A SPACELABS FIELD SERVICE ENGINEER CONFIRMED THAT THE EQUIPMENT PERFORMED TO SPECIFICATIONS. THE INVOLVED CUFF WAS SENT TO SPACELABS FOR FURTHER INVESTIGATION. ADDITIONAL INVESTIGATION OF THE CUFF WAS PERFORMED BY (B)(6) FOR MEDICAL PRODUCT SAFETY PER THEIR STANDARD. THE PATIENT DID NOT WEAR THE RECOMMENDED JERSEY CUFF PROTECTOR. THIS CUFF PROTECTOR ACTS AS AN INSULATOR AND PREVENTS ANY RESIDUAL CLEANING AGENT THAT MAY BE ON THE CUFF FROM IRRITATING SENSITIVE SKIN. THE ANMS REPORT CONCLUDED THAT RESIDUAL CLEANING AGENT ON THE CUFF WAS THE SOURCE OF THE REPORTED INJURY. THE CUSTOMER USES HEXANIOS FOR CLEANING THESE CUFFS. THE HEXANIOS SAFETY DATA SHEET LISTS SKIN IRRITATION AS A POSSIBLE HAZARD. SPACELABS¿ USER MANUAL DOES NOT LIST HEXANIOS AS A SPACELABS RECOMMENDED CLEANING AGENT. THERE WAS NO SPACELABS PRODUCT MALFUNCTION. THE CUSTOMER NOW ROUTINELY USES THE CUFF PROTECTOR TO PREVENT SKIN IRRITATION WHICH HAS RESOLVED THE ISSUE. THIS REPORT IS FINAL AND THE ISSUE IS CLOSED. PLACEHOLDER.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT ON (B)(4) 2014 FROM A CUSTOMER IN (B)(6) THAT A PATIENT WEARING A SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF MODEL 015-0068-04Q DEVELOPED A SKIN RASH WITH BLISTERS AFTER PRODUCT USE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137005 SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF ADULT AMBULATORY BLOOD PRESSURE CUFF DSI SPACELABS HEALTHCARE INC. D 201403

    Patients

    Seq Age Sex Outcome Treatment
    1 Other