MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-06-10 for NEOTREND-L SENSOR N7004-L manufactured by Diametrics Medical, Ltd..
[400700]
The user was unable to insert the neotrend-l sensor into the umbilical artery catheter (vac). The sensor was removed and returned to the mfr for investigation. No report of adverse event or pt-related problem.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9612233-2004-00010 |
MDR Report Key | 594176 |
Report Source | 07 |
Date Received | 2004-06-10 |
Date of Report | 2004-05-07 |
Date of Event | 2004-05-05 |
Date Mfgr Received | 2004-05-21 |
Device Manufacturer Date | 2003-10-01 |
Date Added to Maude | 2005-04-25 |
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 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MISS J. WALTERS |
Manufacturer Street | SHORT STREET, HIGH WYCOMBE |
Manufacturer City | BUCKS HP112QH |
Manufacturer Country | UK |
Manufacturer Postal | HP11 2QH |
Manufacturer Phone | 494471671 |
Manufacturer G1 | DIAMETRICS MEDICAL LIMITED |
Manufacturer Street | GEORGE STREET, HIGH WYCOMBE |
Manufacturer City | BUCKS HP112XJ |
Manufacturer Country | UK |
Manufacturer Postal Code | HP11 2XJ |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | NEOTREND-L SENSOR |
Generic Name | BLOOD GLAS MONITORING SYSTEM |
Product Code | CCE |
Date Received | 2004-06-10 |
Returned To Mfg | 2004-05-11 |
Model Number | N7004-L |
Catalog Number | N7004-L |
Lot Number | 907 |
ID Number | * |
Device Expiration Date | 2005-03-01 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | NA |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 584003 |
Manufacturer | DIAMETRICS MEDICAL, LTD. |
Manufacturer Address | GEORGE ST. HIGH WYCOMBE, BUCKS. UK HP11 2XJ |
Baseline Brand Name | NEOTREND-L SENSOR |
Baseline Generic Name | BLOOD GLAS MONITORING SYSTEM |
Baseline Model No | N7004-L |
Baseline Catalog No | N7004-L |
Baseline ID | * |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2004-06-10 |