AIRBORNE LIFE SUPPORT SYSTEM 185A+ *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-02 for AIRBORNE LIFE SUPPORT SYSTEM 185A+ * manufactured by International Biomedical, Inc..

Event Text Entries

[383469] A newborn was being transported from the delivery room to the nursery in an airborn infant transport incubator system, model # 185a+. The isolette is equipped with a power strip mounted inside of the transport cart. The power strip's electrical cord fell to the ground as the isolette was wheeled into the elevator. The doors closed and as the elevator descended, the entrapped cord caused the isolette to rise, striking the ceiling of the elevator. The plexiglass shattered and the infant fell out of the isolette. The non-retractable electrical cord then snapped causing the isolette to fall.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1034529
MDR Report Key	571063
Date Received	2005-02-02
Date of Report	2005-01-19
Date of Event	2004-11-19
Date Added to Maude	2005-02-09
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	RISK MANAGER
Health Professional	3
Initial Report to FDA	0
Report to FDA	0
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	AIRBORNE LIFE SUPPORT SYSTEM
Generic Name	INFANT TRANSPORT INCUBATOR SYSTEM
Product Code	FPL
Date Received	2005-02-02
Returned To Mfg	2005-01-04
Model Number	185A+
Catalog Number	*
Lot Number	*
ID Number	*
Operator	LAY USER/PATIENT
Device Availability	R
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	560913
Manufacturer	INTERNATIONAL BIOMEDICAL, INC.
Manufacturer Address	8508 CROSS PARK DR AUSTIN TX 787544557 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2005-02-02