MEDGRAPHICS PROFILER SERIES SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-30 for MEDGRAPHICS PROFILER SERIES SYSTEM manufactured by Medical Graphics Corp..

Event Text Entries

[1483026] Pt was having a pulmonary function test. While attempting to proceed with the test on inhalation, the screen contained in the prevent pneumotach dislodged and was swallowed by the pt. The screen from the prevent was lodged in the pt's esophagus. Dates of use: last date used (b) (6) 2009. Diagnosis or reason for use: equipment used with pulmonary function testing. Cleaned by staff in pulmonary function.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5015354
• MDR Report Key: 1649718
• Date Received: 2010-03-30
• Date of Report: 2010-03-23
• Date of Event: 2009-12-18
• Date Added to Maude: 2010-04-06
• 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: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: MEDGRAPHICS PROFILER SERIES SYSTEM
• Generic Name: PRE-VENT PNEUMOTACH-A PART OF THE PT CIRCUIT INSTALLATION-ME
• Product Code: JAX
• Date Received: 2010-03-30
• ID Number: PAT# 5038773
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDICAL GRAPHICS CORP.
• Manufacturer Address: 350 OAK GROVE PARKWAY ST. PAUL MN 55127 US 55127

Device Sequence Number: 2

• Brand Name: MEDGRAPHICS ELITE SERIES PLETHYSMOGRAPH
• Generic Name: PRE-VENT PNEUMOTACH-A PART OF THE PT CIRCUIT INSTALLATION-MEASURES MOUTH PRESSUR
• Product Code: JAX
• Date Received: 2010-03-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MEDICAL GRAPHICS CORP.
• Manufacturer Address: 350 OAK GROVE PARKWAY ST. PAUL MN 55127 US 55127

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2010-03-30