MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-05-01 for DRI-TEK BG-OX CARTRIDGE D7120 946-003 manufactured by Radiometer Medical Aps.
[465430]
Air bubbles may be trapped on or close to the 02 sensor on some cuvettes. Air bubbles may lead to erroneous po2 results without questioning the results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2006-00025 |
| MDR Report Key | 708133 |
| Report Source | 00 |
| Date Received | 2006-05-01 |
| Date of Report | 2006-05-01 |
| Date of Event | 2006-03-15 |
| Date Mfgr Received | 2006-03-15 |
| Date Added to Maude | 2006-05-08 |
| 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 | 0 |
| Manufacturer Contact | LISE-LOTTE RINGBY |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer Phone | 8273827 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRI-TEK BG-OX CARTRIDGE |
| Generic Name | CARTRIDGE FOR NPT7 BLOOD GAS ANALYZER |
| Product Code | JJS |
| Date Received | 2006-05-01 |
| Model Number | D7120 |
| Catalog Number | 946-003 |
| Lot Number | 299 |
| ID Number | * |
| Device Expiration Date | 2008-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 697201 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DA 2700 |
| Baseline Brand Name | DRI-TEK BG-OX CARTRIDGE |
| Baseline Generic Name | CARTRIDGE FOR NPT7 BLOOD GAS ANALYZER |
| Baseline Model No | D7120 |
| Baseline Catalog No | 946-003 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-01 |