MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2005-09-15 for TC MONITOR TCM 4 * manufactured by Radiometer Medical Aps.
[408321]
Using a certain sequence of commands the instrument could report a wrong patient id.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2004-00020 |
| MDR Report Key | 661907 |
| Report Source | 01,05,06 |
| Date Received | 2005-09-15 |
| Date of Report | 2004-12-10 |
| Date Mfgr Received | 2004-01-15 |
| Date Added to Maude | 2006-01-12 |
| 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 | LEIF GUDNITZ, CONSULTANT |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Manufacturer Phone | 8273228 |
| Manufacturer G1 | RADIOMETER MEDICAL APS |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3002807-12/10/2004-003-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TC MONITOR |
| Generic Name | TRANCUTANEOUS OXYGEN AND CARBONDIOXIDE MONIT |
| Product Code | KLK |
| Date Received | 2005-09-15 |
| Model Number | TCM 4 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 651316 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | * * * |
| Baseline Brand Name | TC MONITOR |
| Baseline Generic Name | TRANCUTANEOUS OXYGEN AND CARBONDIOXIDE MONIT |
| Baseline Model No | TCM 4 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-09-15 |