AIRBOURNE 20H N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-04 for AIRBOURNE 20H N/A manufactured by Spectrum Aeromed, Inc..

Event Text Entries

[1476911] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1846675
• MDR Report Key: 1846675
• Date Received: 2010-08-04
• Date of Report: 2010-08-04
• Date of Event: 2010-06-13
• Report Date: 2010-08-04
• Date Reported to FDA: 2010-08-04
• Date Added to Maude: 2010-09-28
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AIRBOURNE
• Generic Name: INCUBATOR, INFANT
• Product Code: FPL
• Date Received: 2010-08-04
• Model Number: 20H
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: *
• Device Availability: Y
• Device Age: 8 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SPECTRUM AEROMED, INC.
• Manufacturer Address: 304 4TH ST. N. WHEATON MN 56296 US 56296

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-08-04