REUSABLE WEIGHTED COLLAR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-02-04 for REUSABLE WEIGHTED COLLAR * manufactured by Utah Medical Products, Inc..

Event Text Entries

[15003781] Infant pt was resting in a bassinet, under an infant warmer with an oxygen hood in place. Oxygen hood was placed over the infant's head and was attached to an oxygen air blender for administration of 100% oxygen. As staff approached the bassinet, they observed a flash of flames under the oxygen hood. Staff removed hood and removed oxygen from the wall. Staff used a blanket to extinguish the fire.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 990603
• MDR Report Key: 990603
• Date Received: 2008-02-04
• Date of Report: 2008-01-30
• Date of Event: 2008-01-22
• Date Facility Aware: 2008-01-22
• Report Date: 2008-01-30
• Date Reported to FDA: 2008-01-30
• Date Reported to Mfgr: 2008-01-30
• Date Added to Maude: 2008-02-05
• 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: 3
• 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 Sequence Number: 1

• Brand Name: REUSABLE WEIGHTED COLLAR
• Generic Name: WEIGHTED COLLAR
• Product Code: FOG
• Date Received: 2008-02-04
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 2.5 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 959176
• Manufacturer: UTAH MEDICAL PRODUCTS, INC.
• Manufacturer Address: 7043 SOUTH 300 WEST MIDVALE UT 84047 US

Device Sequence Number: 2

• Brand Name: DISPOSA HOOD
• Generic Name: OXYGEN HOOD
• Product Code: FOG
• Date Received: 2008-02-04
• Model Number: 0305W
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 959184
• Manufacturer: UTAH MEDICAL PRODUCTS, INC.
• Manufacturer Address: 7043 SOUTH 300 WEST MIDVALE UT 84047 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention	2008-02-04