NEOTREND-L SENSOR N7004L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2004-08-13 for NEOTREND-L SENSOR N7004L manufactured by Diametrics Medical Limited.

MAUDE Entry Details

• Report Number: 9612233-2004-00018
• MDR Report Key: 888394
• Report Source: 06,07
• Date Received: 2004-08-13
• Date of Report: 2004-07-19
• Date of Event: 2004-07-11
• Date Mfgr Received: 2004-07-19
• Device Manufacturer Date: 2003-12-01
• Date Added to Maude: 2007-08-03
• 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: RESPIRATORY THERAPIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: MISS J WALTERS
• Manufacturer Street: SHORT STREET
• Manufacturer City: HIGH WYCOMBE, BUCKS HP112QH
• Manufacturer Country: UK
• Manufacturer Postal: HP11 2QH
• Manufacturer Phone: 494471671
• Manufacturer G1: DIAMETRICS MEDICAL LIMITED
• Manufacturer Street: GEORGE STREET
• Manufacturer City: HIGH WYCOMBE, BUCKS HP112XJ
• Manufacturer Country: UK
• Manufacturer Postal Code: HP11 2XJ
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NEOTREND-L SENSOR
• Generic Name: BLOOD GAS MONITORING SYSTEM
• Product Code: CCE
• Date Received: 2004-08-13
• Returned To Mfg: 2004-07-19
• Model Number: N7004L
• Catalog Number: N7004L
• Lot Number: 910
• ID Number: *
• Device Expiration Date: 2005-05-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 865856
• Manufacturer: DIAMETRICS MEDICAL LIMITED
• Manufacturer Address: GEORGE ST. HIGH WYCOMBE, BUCKS. UK HP11 2XJ

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-08-13