MAUDE MDR 1846675

MDR report key
1846675
Report number
1846675
Event key
0
Event type
3
Date of event
2010-06-13
Date received
2010-08-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AIRBOURNEINCUBATOR, INFANTSPECTRUM AEROMED, INC.FPL20HN/AN/A Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-08-040

Event Narratives#

D

Patient 1

PREMATURE INFANT WAS BEING TRANSPORTED TO HOSPITAL. INFANT WAS PLACED IN PRE-WARMED ISOLETTE AND FOLLOW UP TEMPERATURE WAS LOW. ISOLETTE WAS TURNED UP TO MAXIMUM SETTINGS WITH INFANT'S TEMPERATURE CONTINUING TO DECREASE TO A LOW OF 35.6. ISOLETTE READING 38.5-39 DEGREES, BUT DID NOT "FEEL" THAT WARM. INFANT PLACED ON WARMER AND "NESTED" IN BLANKETS. THE AIR CONDITIONING IN THE JET AND AMBULANCE WAS TURNED OFF. INFANT WARMED BACK UP TO 36.5 AND MAINTAINED ADEQUATE TEMPERATURE THEREAFTER. ALSO HAD "SYSTEM FAILURE" ALARM ON ISOLETTE, WHICH WAS CORRECTED WITH TURNING OFF AND RESTARTING. ISOLETTE WAS EVALUATED BY BIOMED AND TAKEN OUT OF SERVICE FOR REPAIR. BABY'S TEMPERATURE DID NOT MATCH SET TEMPERATURE. SET CONTROLLER AT 37 DEGREE CELSIUS AND MEASURED 4 INCHES ABOVE MATTRESS AT CENTER OF CHAMBER. TEMPERATURE WAS 1.5 DEGREE LOWER THAN SET POINT WITH CONTROLLER INDICATING SET POINT REACHED. ATTEMPT ADJUSTMENT/CONTACTED COMPANY AS SERVICE MANUAL SETTINGS COULD NOT BE REACHED. WITH HELP OF COMPANY TECHNICIAN, THERE WAS AN ADJUSTMENT TO THE CONTROL BOARD SETTINGS TO ACHIEVE A REFERENCE POINT FOR STARTING TEMPERATURE ADJUSTMENT. THE TEMPERATURE WAS NOT REGULATING WELL AND SUSPECT NON-LINEAR TEMPERATURE PROBE. ORDERED REPLACEMENT SENSORS.