MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-07-14 for TRANSCUTANEOUS BLOOD GAS MONITOR TCM400 SERIES 391-880 manufactured by Radiometer Medical Aps.
[4644596]
The patient received a second degree burn mark on the top of his right foot, after the tcm400 sensor was removed. The temperature was set to 44 degrees celsius, and the electrode was placed on the same location for 2 hours.
Patient Sequence No: 1, Text Type: D, B5
[12098217]
The tcm400 has been checked, and no indications of product malfunction were identified. It is stated in the intended use that the tcm400 system should not be used in icu and for unattended patient monitoring, as the system has no alarms. Also the following warnings are included: in this case the patient was suffering from critical limb ischemia. This condition results in reduced blood flow to the feet, and the placement of the electrode in the same position for two hours is therefore suspected to have caused the burn mark.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2014-00021 |
| MDR Report Key | 3950972 |
| Report Source | 01,07 |
| Date Received | 2014-07-14 |
| Date of Report | 2014-06-13 |
| Date of Event | 2014-05-17 |
| Date Mfgr Received | 2014-06-13 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2014-07-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Manufacturer Phone | 8273827 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSCUTANEOUS BLOOD GAS MONITOR |
| Generic Name | TCM400 |
| Product Code | LPP |
| Date Received | 2014-07-14 |
| Model Number | TCM400 SERIES |
| Catalog Number | 391-880 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DK-2700 DA DK-2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-14 |