AIRBORNE LIFE SUPPORT SYSTEMS 20-H *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-09-13 for AIRBORNE LIFE SUPPORT SYSTEMS 20-H * manufactured by International Biomedical, Inc..

Event Text Entries

[14873189] Unit was mounted in an ambulance which was involved in a motor vehicle accident. When the ambulance rolled over, the middle part of the unit separated from the bottom part of the unit because of a latch failure. Unit destroyed. No pt in unit at time of accident.
Patient Sequence No: 1, Text Type: D, B5

[16280722] Unit was mounted in ambulance which was involved in a motor vehicle accident. When the ambulance rolled over, the middle part of the unit separated form the bottom part of the unit because of a latch failure. Unit destroyed. No pt in unit at time of accident.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1019897
MDR Report Key	296122
Date Received	2000-09-13
Date of Report	2000-08-31
Date of Event	2000-08-26
Date Added to Maude	2000-09-18
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	0
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 SYSTEMS
Generic Name	LIFE SUPPORT SYSTEM
Product Code	FPL
Date Received	2000-09-13
Model Number	20-H
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	N
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	286632
Manufacturer	INTERNATIONAL BIOMEDICAL, INC.
Manufacturer Address	P.O. BOX 143449 AUSTIN TX 787544557 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2000-09-13