MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02 report with the FDA on 2005-02-09 for TC MONITOR TCM4 * manufactured by Radiometer Medical Aps.
[393511]
It has been discovered within radiometer, that a rapid switching of the instrument off and on may cause the build-in acoustical alarm to remain silent when tripped. The visual alarm remains unaffected. Radiometer has received no reports about this from the field and no harm to any pt has occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2005-00001 |
| MDR Report Key | 575957 |
| Report Source | 01,02 |
| Date Received | 2005-02-09 |
| Date of Report | 2005-02-04 |
| Date Added to Maude | 2005-02-28 |
| 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 |
| Manufacturer City | BRONSHOJ 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer Phone | ** |
| Manufacturer G1 | RADIOMETER MEDICAL APS |
| Manufacturer Street | AKANDEVEJ |
| Manufacturer City | BRONSHOJ 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2700 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3002807968-02/02/2005-00 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TC MONITOR |
| Generic Name | TRANSCUTANEOUS OXYGEN AND CARBONDIOXIDE MONI |
| Product Code | KLK |
| Date Received | 2005-02-09 |
| Model Number | TCM4 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 565807 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | * * * |
| Baseline Brand Name | TC MONITOR |
| Baseline Generic Name | TRANSCUTANEOUS OXYGEN AND CARBONDIOXIDE MONI |
| Baseline Model No | TCM4 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-09 |