BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESUSCITAIRE REDIANT WARMER

    MDR report key: 148089 · Received February 6, 1998

    Report

    Report Number
    2510954-1998-00001
    Event Type
    Malfunction
    Date Received
    February 6, 1998
    Report Date
    January 7, 1998
    Manufacturer
    AIR- SHIELDS
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS REPRODUCED BY HILL-ROM AIR-SHIELDS BY INCREASING HEATER CIRCUIT RESISTANCE TO AN OUT-OF-SPECIFICATION CONDITION, DUPLICATING THE CONDITIONS REPORTED BY THE COMPLAINANT. IN THIS CONDITION THE SOFTWARE CHANGED STATE TO ALLOW THE SYSTEM TO OPERATE USING NOMINAL VALUES FOR POWER AND AN ALGORITHM TIMER WAS NOT RELOADED. THE SOFTWARE WAS CHANGED TO CORRECT THIS PROBLEM. ADDITIONALLY, TOLERANCES WITH TIME RESTRICTIONS WERE ADDED FOR THE SOFTWARE TO QUESTION THE VALIDITY OF THE SYSTEM STATE BASED ON POSSIBLY ERRONEOUS POWER READINGS TO ALLOW THE SYSTEM TO OPERATE CORRECTLY WITH OUT-OF-SPECIFICATION HEATER CIRCUIT RESISTANCE. A VOLUNTARY RECALL WAS INITIATED 6/12/1998 WITH FULL KNOWLEDGE AND SUPPORT OF FDA. REFERENCE RECALL NOTIFICATION. REASON FOR RECALL: HILL-ROM AIR-SHIELDS HAS RECEIVED REPORTS FROM DEVICE USERS INDICATING FAILURES TO PROPERLY CONTROL HEATER POWER AS DEFINED IN (1) AND (2) BELOW: 1. FAILURE TO REDUCE HEATER POWER TO 30% AFTER FIFTEEN (15) MINUTES IN PRE-WARM OPERATION MODE. HEATER POWER REMAINED AT 100% WHILE THE HEATER DISPLAY INDICATED 30% HEATER POWER. 2. IN SKIN TEMPERATURE (SERVO) CONTROL, FAILURE TO PROVIDE APPROPRIATE HEATER POWER AFTER THE SET TEMPERATURE WAS REACHED. HEATER POWER WOULD REDUCE APPROPRIATELY AS THE SET TEMPERATURE WAS REACHED, BUT WOULD NOT INCREASE IN RESPONSE TO DECREASING SKIN TEMPERATURE. NOTE: THE LOW SKIN SET TEMPERATURE ALARM WOULD ACTIVATE. NOTE: NO INJURIES HAVE BEEN REPORTED TO HILL-ROM AIR-SHIELDS AS A RESULT OF THESE FAILURES TO PROPERLY CONTROL HEATER POWER. CORRECTIVE ACTION: SOFTWARE VERSION 1.061 PROVIDES PROPER HEATER POWER CONTROL THROUGH AN INCREASED RANGE OF LINE VOLTAGE AND HEATER CIRCUIT RESISTANCE. REQUIRED ACTION: 1. UPDATE ALL RESUSCITAIRE INFANT RADIANT WARMERS TO SOFTWARE VERSION 1.061. HILL-ROM AIR-SHIELDS SOFTWARE REPLACEMENT KIT PART NUMBER IS 82 900 02 AND WILL BE PROVIDED FREE OF CHARGE. INSTALLATION WILL BE PROVIDED AS REQUIRED. 2. TO ARRANGE THE UPGRADE OF SOFTWARE TO VERSION 1.061 CUSTOMERS SHOULD CONTACT HILL-ROM AIR-SHIELDS QUALITY ASSURANCE DEPARTMENT AT THE APPROPRATE NUMBER LISTED BELOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE PRE-WARM MODE OF OPERATION THE HEATER POWER DID NOT REDUCE TO 30 PERCENT AFTER FIFTEEN MINUTES AS REQUIRED. THE RADIANT WARMER WAS REPORTED TO REMAIN AT FULL POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESUSCITAIRE REDIANT WARMER INFANT RADIANT WARMER FMT AIR- SHIELDS RW82 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN