GMS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-12-06 for GMS manufactured by Datex-ohmeda.

Event Text Entries

[764739] Customer reported difficulty ventilating a patient due to a leak in the gms absorber. There was no reported patient injury. Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2112667-2007-00054
• MDR Report Key: 961583
• Report Source: 05
• Date Received: 2007-12-06
• Date of Report: 2007-12-06
• Date of Event: 2007-11-14
• Date Mfgr Received: 2007-11-14
• Device Manufacturer Date: 1992-01-01
• Date Added to Maude: 2008-03-24
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: ANN LEBAR
• Manufacturer Street: 9900 INNOVATION DR. MAIL STOP: RP2138
• Manufacturer City: WAUWATOSA WI 53226
• Manufacturer Country: US
• Manufacturer Postal: 53226
• Manufacturer Phone: 4147213947
• Manufacturer G1: DATEX-OHMEDA
• Manufacturer City: MADISON WI
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GMS
• Generic Name: CARBON DIOXIDE ABSORBER
• Product Code: BSF
• Date Received: 2007-12-06
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 966915
• Manufacturer: DATEX-OHMEDA
• Manufacturer Address: MADISON WI US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-12-06