BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF

    MDR report key: 5089498 · Received September 18, 2015

    Report

    Report Number
    9611295-2015-00005
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    September 9, 2014
    Report Date
    September 18, 2015
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    DXN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SENT TO CORRECT THE MANUFACTURER INFORMATION. THE OLD REPORT NUMBER WAS 3010157426-2014-00064. 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) REGULATORY AGENCY 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 (B)(6) 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.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT ON SEPTEMBER 12, 2014 FROM A CUSTOMER IN (B)(6) THAT A PATIENT WEARING A SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF MODEL 015-0068-04Q DEVELOPED A RED AND BROWN SKIN RASH WITH BURN MARKINGS AFTER PRODUCT USE. THIS WAS DISCOVERED BY THE CUSTOMER ON (B)(6) 2014 WHEN THE PATIENT ARRIVED AT THE FACILITY FOR REMOVAL OF THE CUFF WHICH WAS APPLIED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620662 SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF ADULT AMBULATORY BLOOD PRESSURE CUFF DXN SPACELABS HEALTHCARE LTD. D 201403

    Patients

    Seq Age Sex Outcome Treatment
    1 Other