5250 RESPIRATORY GAS MONITOR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-19 for 5250 RESPIRATORY GAS MONITOR * manufactured by Datex-ohmeda, Inc..

Event Text Entries

[354411] On awake extubation, clearish/brown tinged fluid with some particulates spewed out of the ett [endotracheal tube] into the circuit. The patient's etco2 [end tidal carbon dioxide] had run high during spontaneous ventilation. During anesthetic, rgm [respiratory gas monitor] had malfunctioned and [also] at the beginning of the case. The rgm was changed and a new rgm was reading erroneously as well. The device would bounce from 13 to 83 to 61 in subsequent breaths. The patient had rsi [rapid sequence induction] with no unusual events at induction. No unusual occurrences during case except equipment problems as noted above. The stomach was decompressed. The patient awakened. Saturations [were] 99% in recovery. No coughing or respiratory distress.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 521741
• MDR Report Key: 521741
• Date Received: 2004-04-19
• Date of Report: 2004-03-01
• Date of Event: 2004-02-01
• Date Added to Maude: 2004-04-26
• 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: 5250 RESPIRATORY GAS MONITOR
• Generic Name: RESPIRATORY GAS MONITOR
• Product Code: CCL
• Date Received: 2004-04-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: STOCK 6051000027
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 510869
• Manufacturer: DATEX-OHMEDA, INC.
• Manufacturer Address: 3030 OHMEDA DRIVE MADISON WI 53718 US

Device Sequence Number: 2

• Brand Name: 5250 RESPIRATORY GAS MONITOR
• Generic Name: RESPIRATORY GAS MONITOR
• Product Code: CCL
• Date Received: 2004-04-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: STOCK 6051000027
• Implant Flag: N
• Device Sequence No: 2
• Device Event Key: 524025
• Manufacturer: DATEX-OHMEDA, INC.
• Manufacturer Address: 3030 OHMEDA DRIVE MADISON WI 53718 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-04-19