MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-07-07 for NEOTREND-L SENSOR N7004L manufactured by Diametrics Medical Limited.
[381248]
The neotrend-l sensor was calibrated without problems. The user reported that the trendcare monitor then gave an indication that the sensor was bent or damaged before an attempt was made to advance the sensor. The sensor was then advanced, but was very stiff and did not advance fully. Blood came back from the umbilical artery catheter (uac) into the sensor. No harm or injury to the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612233-2004-00012 |
| MDR Report Key | 610428 |
| Report Source | 07 |
| Date Received | 2004-07-07 |
| Date of Report | 2004-06-09 |
| Date of Event | 2004-03-28 |
| Date Mfgr Received | 2004-06-09 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2005-06-07 |
| 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 | GEORGE STREET, HIGH WYCOMBE |
| Manufacturer City | BUCKS HP112XJ |
| Manufacturer Country | UK |
| Manufacturer Postal | HP11 2XJ |
| Manufacturer Phone | 494471671 |
| Manufacturer G1 | DIAMETRICS MEDICAL LIMITED |
| Manufacturer Street | SHORT STREET, HIGH WYCOMBE |
| Manufacturer City | BUCKS HP112QH |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HP11 2QH |
| 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 GAS MONITORING SYSTEM |
| Product Code | CCE |
| Date Received | 2004-07-07 |
| Returned To Mfg | 2004-06-10 |
| Model Number | N7004L |
| Catalog Number | N7004L |
| Lot Number | 892 |
| ID Number | * |
| Device Expiration Date | 2004-09-01 |
| 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 | 600224 |
| Manufacturer | DIAMETRICS MEDICAL LIMITED |
| Manufacturer Address | GEORGE STREET HIGH WYCOMBE, BUCKS. UK HP11 2XJ |
| Baseline Brand Name | NEOTREND-L MULTIPARAMETER SENSOR |
| Baseline Generic Name | NEOTREND |
| Baseline Model No | N7004L |
| Baseline Catalog No | N7004L |
| Baseline ID | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K972314 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-07-07 |