Summary of MedSun Reports Describing Adverse Events With Infant Radiant Warmers and Neonatal Incubators And Related Recalls and Articles
MedSun: Newsletter #27, August 2008
By Elizabeth Eydelman, Patient Safety Staff, 2008
Over the past year and a half, MedSun has received 8 adverse event reports involving infant radiant warmers and neonatal incubators associated with three manufacturers: Draeger Medical (5), Datex-Ohmeda, Inc. (2), and GE Medical Systems, LLC (1). The reports were submitted by 8 hospitals between January 1st 2007 and May 16th 2008, and involved neonatal patients. Reported device problems are:
•Melting of incubator components/components ignite or smoke (3)
•Overheating of incubator occupant (2)
•Sharp edges or high temperatures are hazards to health care professionals (2)
•Failure of Incubator to heat (1)
Four of the reports that list adverse event type as malfunction and the remaining have event types listed as invalid/insufficient data. There are no reports with event types listed as death, injury, or other. Of the reports that list patient problems, the most frequently reported patient problems are:
•Elevated infant body temperature (2)
•Burns to health care professional (1)
•Cuts to health care professional (1)
These reports contribute to FDA’s post-market experience and understanding of problems associated with the use of these devices.
Additionally, the following recall describes a problem involving a heating failure with the Draeger TI500 Isolette Infant Incubator:
The recall, Z-1051-2008 dated January 31, 2008, was initiated for a Draeger TI500 Isolette Infant Incubator Catalog Number: MU20505 by Draeger Medical, Inc., Telford, PA 18969. The product is under recall due to a heating failure involving a power board which controls the incubator heater that may not regulate the temperature properly. This, in turn, results in a high temperature alarm and a loss of temperature control within the patient compartment.
“Don’t Let Radiant Warmers Overheat Infants,” an article in the March Issue of Nursing2006, provides the following precautions for infant incubator radiant warmer use:
•Follow your facility’s policies and procedures for infant incubators and warmers.
•Review and follow manufacturer service manual and instructions for use
•Verify patient skin temperatures being monitored by incubators/warmers by frequent axillary skin temperature checks.
[Note: The reports have been edited for clarity]
|Device||Device Identifiers||Event Description|
|Draeger Medical Systems, Inc./Infant Radiant Warmer||Model: 7880||RADIANT WARMER USED TO WARM INFANT AFTER AXILLARY TEMPERATURE 97.3F. SKIN PROBE PLACED OVER LIVER IN RUQ (RIGHT UPPER QUADRANT) OF ABDOMEN AND CONTROL POINT SET AT 37.1C (98.6F). WHEN SKIN TEMP REACHED 36.1C, MACHINE PRODUCED LITTLE TO NO HEAT AND KEPT ALARMING. AT 2135, INFANT TRANSFERRED TO ANOTHER WARMER WHICH READ HIS SKIN TEMP AT 35.8 (96.6F)AND HIS AXILLARY TEMP WAS 97.2F AT THIS TIME.|
|GE Medical Systems, LLC/Neonatal Incubator||Model: Giraffe Omnibed||THE PLASTIC MOLDING AROUND THE PLUG OF THE AC POWER CORD WAS MELTED. THIS IS ON THE FEMALE END OF THE POWER CORD THAT INSERTS INTO THE DEVICE ITSELF (NOT THE WALL OUTLET SIDE). IT ALSO HAD A "BURNT ELECTRICAL" SMELL UPON FURTHER EXAMINATION. THIS WAS FOUND DURING ANNUAL PLANNED MAINTENANCE. IT IS UNKNOWN HOW LONG THIS CONDITION EXISTED WHILE THE DEVICE WAS IN USE AS NO COMPLAINTS WERE EVER LOGGED. FOLLOW-UP REVEALS THAT THE AC RECEPTACLE IN THE GIRAFFE IS DESIGNED TO HOLD THE POWER CORD IN PLACE USING AN L-SHAPED BRACKET. THEORETICALLY THIS WOULD PREVENT IT FROM BEING UNPLUGGED ACCIDENTALLY. APPARENTLY THE POWER CORD WAS LOOSE FOR SOME TIME PRIOR TO BEING DISCOVERED DURING A ROUTINE ELECTRICAL SAFETY INSPECTION. THE DAMAGED POWER CORD WAS GIVEN TO A COMPANY SALES REPRESENTATIVE. THE REPRESENTATIVE NOTED THAT THE CORD WAS A DIFFERENT TYPE (BLACK VERSUS GRAY) THAN HE HAD SEEN BEFORE. THE HOSPITAL HAS ONLY ONE OF THESE INCUBATORS.|
|Draeger Medical Systems, Inc./Infant Radiant Warmer||Model: IICS-90||EACH INFANT WARMER HAS A DOUBLE CYLINDER HOLDER MOUNTED ONTO EACH UNIT. PLASTIC KNOBS WITH THREADED SCREWS HOLD E OXYGEN CYNLINDER TANKS IN PLACE. THE PLASTIC KNOBS STICK OUT, AND 2 HAD BECOME BROKEN JUST BY MOVING THE WARMERS AROUND IN THE STORAGE ROOM. WHEN THE PLASTIC KNOB BREAKS, THEY BREAK IN SUCH A MANNER THAT LEAVES VERY SHARP EDGES. MYSELF AND ANOTHER BIOMED HAD OUR FINGERS SLICED BY THE SHARP PLASTIC, AND THEREFORE REPLACED THE PLASTIC KNOBS WITH DIFFERENT SCREWS MADE STRICTLY OUT OF METAL, WITH A FLAT END THE USER CAN GRIP TO TURN AND TIGHTEN.|
|Draeger Medical Systems, Inc./Neonatal Incubator||Model: C2HS-1||RN FOUND NEONATE TACHYCARDIC, TACHYPNEIC AND DECREASED SATURATIONS. BOTH BABY AND ISOLETTE WERE VERY WARM. WAS SET ON SERVO CONTROL BUT WAS FOUND ON AIR CONTROL, ATTEMPT TO CHANGE BUT ALARMED 'PROBE MALFUNCTION.' UNABLE TO CHANGE TO SERVO CONTROL. HAD TO TURN BED OFF TO DECREASE NEONATE'S TEMP FROM 101.9. AFTER TEMP DECREASED, ATTEMPT TO TURN BED BACK ON WAS UNSUCCESSFUL.|
|Datex-Ohmeda, Inc./Infant Radiant Warmer||Catalog: 6650-004-901||WHEN THE NURSE BENT DOWN TO PLUG IN AN INFUSION PUMP, HER KNEE GAVE OUT WHEN ATTEMPTING TO STAND, WHICH CAUSED HER TO BUMP INTO AND LEAN ON THE HUMIDIFIER END OF THE DATEX-OHMEDA GIRAFFE OMNIBED. THE HUMIDIFIER WAS ON AND RUNNING, SO THE WATER WAS HEATED. INVESTIGATION FOUND THE WATER RUNNING AT GREATER THAN 150 DEGREES F (158 F), AND THE TOP SURFACE AREA TO BE AT 118 DEGREES F (NORMAL). AFTER THE EVENT WAS DISCUSSED WITH DATEX-OHMEDA TECHNICAL SUPPORT ENGINEER, IT WAS CONFIRMED THAT THE HEATER ELEMENT ITSELF RUNS AT 200 DEGREES F. THE OPERATING TEMPERATURES AND THE TEMPERATURE WAS WITHIN NORMAL SPECIFICATIONS, THOUGH NOT LISTED IN THE SERVICE MANUAL. WE BELIEVE THE JARRING OF THE UNIT WHEN THE STAFF MEMBER ATTEMPTED TO GAIN HER BALANCE CAUSED THE WATER TO SLOSH IN THE RESERVOIR, AND CAUSED A SMALL 2ND DEGREE BURN (ABOUT THE SIZE OF A NICKEL) WHERE SHE WAS USED THE UNIT FOR SUPPORT. WE HAVE ATTACHED WARNING LABELS TO THE RESERVOIR ON ALL OF OUR DATEX-OHMEDA GIRAFFE OMNIBEDS SO STAFF IS AWARE THAT THIS AREA IS HOT WHEN HUMIDIFIER IS RUNNING.|
|Draeger Medical Systems, Inc./Infant Radiant Warmer||Model: RW82-1||INFANT WARMER IGNITED WHILE UNIT WAS IN THE OPERATING ROOM PENDING DELIVERY OF THE INFANT. THE UNIT WAS IN OPERATION BUT INFANT WAS NOT IN THE BED. A MANUFACTURER'S REPRESENTATIVE CAME TO THE FACILITY TO REPLACE PARTS ON THE DAMAGED UNIT AND WILL BE REPLACING THE HEATER ELEMENTS ON ALL UNITS IN OUR FACILITY. THE HOSPITAL'S BIOMEDICAL ENGINEERING DEPARTMENT HAS REPLACED HEATING UNITS ON FOUR OTHER WARMERS AT THE FACILITY IN THE PAST YEAR, WHICH THEY CONSIDER A HIGH FAILURE RATE.|
|Datex-Ohmeda, Inc./Neonatal Incubator||Model: 600||THE AIR MODE WAS BEING USED TO PREHEAT THE OMNIBED INCUBATOR WHILE AWAITING THE INFANT'S RETURN FROM SURGERY. WHEN THE INFANT WAS PLACED IN THE OMNIBED, THE BED WAS NOT PUT INTO BABY MODE. THIS CAUSED THE OMNIBED TO MAINTAIN AN AIR TEMPERATURE OF 41.7 DEGREES C (107 DEGREES F). THIS ELEVATED AIR TEMPERATURE RESULTED IN AN INCREASE OF THE INFANT'S AXILLARY TEMPERATURE.|
|Draeger Medical Systems, Inc./Neonatal Incubator||Model: C2000||INFANT BEING ASSESSED WHEN NURSE SMELLED ELECTRICAL SMOKE. SMOKE SEEN ABOVE ISOLETTE. INFANT REMOVED FROM ISOLETTE IMMEDIATELY AND PLACED IN A CLEAN ISOLETTE. CHANGE NURSE NOTIFIED. SECURITY CALLED. HOSPITAL BIOMEDICAL CALLED AND NOTIFIED. BIOMEDICAL SHEET FILLED OUT AND ISOLETTE TAKEN TO DIRTY UTILITY ROOM TO BE CLEANED. NO PROBLEMS WITH INFANT.|