OHIO TRANSPORT INCUBATOR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-26 for OHIO TRANSPORT INCUBATOR * manufactured by Ohio Medical Product Ohmeda Co..

Event Text Entries

[109453] Transport incubator plugged in in special care nursery. No babies in this room at this time. Staff member in room noted thick, yellow smoke from area near isolette. Plug cool to touch & transport moved with handles. Transformer melted. Infants moved from nursery immediately. 2 staff members from labor & delivery complained of symptoms. Checked by occupational hlth.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 174297
• MDR Report Key: 174297
• Date Received: 1998-06-26
• Date of Report: 1998-05-05
• Date of Event: 1998-04-28
• Date Facility Aware: 1998-04-28
• Report Date: 1998-05-05
• Date Reported to Mfgr: 1998-05-05
• Date Added to Maude: 1998-06-30
• 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: OHIO TRANSPORT INCUBATOR
• Generic Name: AIRVAC INCUBATOR
• Product Code: FPL
• Date Received: 1998-06-26
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 169462
• Manufacturer: OHIO MEDICAL PRODUCT OHMEDA CO.
• Manufacturer Address: OHMEDA DR. PO BOX 7550 MADISON WI 53707 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1998-06-26