BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF

    MDR report key: 5088791 · Received September 18, 2015

    Report

    Report Number
    9611295-2015-00009
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    April 17, 2014
    Report Date
    June 3, 2020
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    DXN
    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) 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. 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, 3010157426-2014-00030, THAT MISTAKENLY IDENTIFIED THE MANUFACTURER REPORT NUMBER; AT FDA FORM 3500A TOP OF PAGE 1 AND MISTAKENLY IDENTIFIED THE MANUFACTURER BY LISTING THE MANUFACTURE¿S AFFILIATE ENTITY.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT ON SEPTEMBER 17, 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
    620663 SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF ADULT AMBULATORY BLOOD PRESSURE CUFF DXN SPACELABS HEALTHCARE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other