BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAEGER ISOLETTE INFANT INCUBATOR

    MDR report key: 1905890 · Received November 18, 2010

    Report

    Report Number
    2510954-2010-00010
    Event Type
    Other
    Date Received
    November 18, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 22, 2010
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    FMZ
    PMA / PMN Number
    K960980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER COMPLETED THE INVESTIGATION FOR THIS REPORT. THE INITIAL CALL FROM BIOMEDICAL ENGINEERING INVOLVED QUESTIONS ABOUT THE TEMPERATURE PROBE, SPECIFICALLY, IF THE PROBE WAS DEFECTIVE, WOULD IT CAUSE THE UNIT TO OVERHEAT AND NOT ALARM. A F/U CALL FROM BIOMEDICAL ENGINEERING INDICATED THAT THEY WANTED DRAEGER TO CHECK THE THREE UNITS AT THE FACILITY FOR PROPER OPERATION SINCE THERE WAS AN INCIDENT A FEW DAYS EARLIER. HOWEVER, THE UNIT INVOLVED COULD NOT BE IDENTIFIED. BIOMEDICAL ENGINEERING CHECKED ALL UNITS FOR PROPER OPERATION AND NO PROBLEMS WERE FOUND. BIOMEDICAL ENGINEERING DID NOT HAVE THE PROBE INVOLVED IN THE INCIDENT. ON (B)(6) 2010 A USER REPORT WAS REC'D FROM THE FACILITY DESCRIBING THE INCIDENT. INFORMATION SUPPLIED BY BIOMEDICAL ENGINEERING INDICATED THE UNIT WAS IN SKIN MODE WITH A SET TEMPERATURE OF 36 DEG C. THE PT WAS REMOVED FROM THE UNIT FOR A BONDING SESSION WITH THE MOTHER. THE PT WAS THEN RETURNED TO THE UNIT. THE STAFF LATER NOTICED THAT THE PT APPEARED AGITATED AND WAS CRYING. THE PT WAS FOUND TO HAVE AN ELEVATED TEMPERATURE OF 102.9 DEG F. THE NURSE NOTED THE AIR TEMPERATURE DISPLAYED TO BE 38.4 DEG C. THE PROBE COVER WAS ATTACHED TO THE PT; HOWEVER, THE DISPOSABLE PROBE WAS FOUND ON THE BED SHEET. THE UNIT REPORTEDLY DID NOT ALARM. THE PT WAS REMOVED, SWADDLED AND MONITORED UNTIL THE TEMPERATURE WAS LOWERED. APPROX TWO HOURS LATER THE PT DEVELOPED RESPIRATORY DISTRESS AND WAS TREATED FOR THE CONDITION PNEUMOTHORAX. THE PT'S CONDITION HAS SINCE IMPROVED AND IS PROGRESSING WELL. THE DRAEGER SERVICE REP TESTED THE THREE UNITS FOR PROPER OPERATION AND FOUND THE UNITS TO OPERATE WITHIN MANUFACTURER SPECIFICATIONS. IN ADDITION, THE ALARMS WERE ACTIVATING WITHIN MANUFACTURER SPECIFICATIONS. THE PROBE ALLEGEDLY INVOLVED IN THE INCIDENT WAS GIVEN TO THE SERVICE REP BY A NURSE IN THE ROOM AT THE TIME OF THE INCIDENT, BUT NOT DIRECTLY INVOLVED FOR TESTING. WHEN THE PROBE WAS INSTALLED THE UNIT IMMEDIATELY ALARMED AND DISPLAYED SKIN PROBE FAILURE WHICH INDICATES THE PROBE IS MECHANICALLY CONNECTED BUT ELECTRICALLY OPEN OR SHORT CIRCUITED. WHEN THIS ALARM OCCURS THE SYSTEM AUTOMATICALLY DISABLES POWER TO THE HEATER. THE 38.4 DEG C TEMPERATURE NOTED BY THE USER WAS THE DISPLAYED AIR TEMPERATURE IN THE PT COMPARTMENT AND IS NOT THE TEMPERATURE BEING CONTROLLED WHILE IN SKIN MODE. THE INSTRUCTIONS FOR USE ADVISE THE USER TO THIS MODE OF OPERATION. THE INSTRUCTIONS FOR USE ALSO INCLUDES THE FOLLOWING WARNING; "WHEN IN SKIN MODE, THE SKIN PROBE MUST BE IN DIRECT CONTACT WITH THE SKIN TO PROVIDE ACCURATE MONITORING OF THE INFANTS TEMPERATURE. WHEN IN SKIN MODE, FAILURE TO MAINTAIN DIRECT SKIN CONTACT CAN RESULT IN OVERHEATING. ROUTINELY CHECK THE INFANT'S CONDITION FOR CORRECT PROBE ATTACHMENT, AND FEEL THE INFANT'S SKIN FOR SIGNS OF OVERHEATING." ADDITIONALLY THE USER MUST CHECK THE CONDITION OF THE INFANT AT LEAST EVERY 15 MINUTES FOR CORRECT PROBE ATTACHMENT, AND FEEL THE SKIN OF THE INFANT FOR SIGNS OF OVERHEATING. BASED ON THE INFORMATION PROVIDED FROM THE USER FACILITY THE SKIN PROBE WAS NOT ATTACHED TO THE INFANT, THEREBY CAUSING THE INCIDENT. IF THE PROBE IS NOT ATTACHED, THIS MAY RESULT IN OVERHEATING OF THE INFANT, AS STATED IN THE ABOVE WARNING. THE PROBE THAT WAS GIVEN TO THE SERVICE REP WHICH WAS REPORTEDLY INVOLVED IN THE INCIDENT IMMEDIATELY PRODUCED A SKIN PROBE FAILURE ALARM. THEREFORE, IT WAS NOT LIKELY TO BE THE PROBE INVOLVED IN THE INCIDENT. THE TESTING PERFORMED ON THE UNITS INDICATED THAT THEY FUNCTIONED IN ACCORDANCE WITH THE MANUFACTURER SPECIFICATIONS AND THE PROBE WAS NOT THE PROBLEM. THE USER FACILITY REQUESTED AN "IN-SERVICE" TO TRAIN STAFF ON PROPER OPERATION OF THE UNITS. THE REQUESTED "IN-SERVICE" RE-TRAINING WAS PERFORMED ON (B)(6) 2010. ADDITIONAL INFORMATION FROM THE USER FACILITY REPORT: (B)(6). HILL-ROM PREMI-PROBE 4S. ISOLETTE SKIN PROBE. MODEL: 0936-01; CATALOG # MU12520-02. (B)(6), RN, BSN; (B)(6).

    Description of Event or Problem · 1

    SEE ATTACHED USER FACILITY REPORT (B)(4) FOR EVENT DESCRIPTION. (B)(4). ADDITIONAL INFORMATION FROM THE USER FACILITY REPORT: A 3 DAY OLD INFANT IN SPECIAL CARE NURSERY FOUND TO HAVE ELEVATED TEMPERATURE 102.9 ON ASSESSMENT FOR AGITATION AND CRYING; AIR TEMPERATURE IN ISOLETTE READ 38.4 DEGREES; THERMAL PROBE COVER WAS FOUND ATTACHED TO INFANT'S SKIN BUT THE SKIN PROBE WAS FOUND ON BED SHEET; ISOLETTE REPORTEDLY DID NOT ALARM. THE INFANT WAS REMOVED FROM THE ISOLETTE, SWADDLED, AND MONITORED CLOSELY UNTIL THE TEMPERATURE LOWERED. APPROX 2 HOURS LATER, THE INFANT DEVELOPED RESPIRATORY DISTRESS; CHEST X-RAY REVEALED 60% TENSION PNEUMOTHORAX. THE INFANT WAS PLACED ON CPAP/PEEP5, 100% OXYGEN; NEEDLE ASPIRATION WAS PERFORMED. F/U CHEST X-RAY SHOWED A SMALL RESIDUAL PNEUMOTHORAX; PNEUMOTHORAX WAS COMPLETELY RESOLVED BY (B)(6) 2010. THE NEONATOLOGIST DOCUMENTED AGITATION DUE TO INCREASED TEMPERATURE MAY HAVE CAUSED THE INFANT'S PNEUMOTHORAX. THE INFANT REMAINS IN THE SPECIAL CARE NURSERY AT THE PRESENT TIME. SHE HAS BEEN ON ROOM AIR SINCE (B)(6) 2010 AND IS PROGRESSING WELL. A TECHNICAL SERVICE REP FROM DRAGER MEDICAL CAME TO THIS HOSPITAL (B)(6) 2010 TO EVALUATE ALL PROBES AND ISOLETTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAEGER ISOLETTE INFANT INCUBATOR INFANT INCUBATOR FMZ DRAEGER MEDICAL SYSTEMS, INC. C2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA