*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-12 for * manufactured by Bird Products Corp.

Event Text Entries

[16270024] Mri vent tested on test lung and found to be operating within correct parameters. Placed on patient and patient seized, developed subcutaneous air in neck and chest. Physician felt patient had a possible air embolus. Chest x-ray revealed pneumothorax.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 120756
• MDR Report Key: 120756
• Date Received: 1997-09-12
• Date of Report: 1997-08-06
• Date of Event: 1997-07-14
• Date Facility Aware: 1997-07-14
• Report Date: 1997-08-06
• Date Reported to FDA: 1997-08-25
• Date Reported to Mfgr: 1997-08-25
• Date Added to Maude: 1997-09-19
• 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: *
• Generic Name: EXHALATION VALVE FOR CIRCUIT
• Product Code: CBP
• Date Received: 1997-09-12
• Returned To Mfg: 1997-08-11
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: PR 02575
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 10 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 118380
• Manufacturer: BIRD PRODUCTS CORP
• Manufacturer Address: 3101 E. ALEJO RD PALM SPRINGS CA 92262 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1997-09-12