MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-29 for TRANSCUTANEOUS BLOOD GAS MONITOR TCM4 SERIES 391-880 manufactured by Radiometer Medical Aps.
[20324047]
The patient (a neonatal boy born in (b)(6) gestation week) received a burn mark on the right thigh. The temperature was set to 43 degrees celsius, and the electrode was placed on the same location for 7 hours. According to the operator's manual (tcm4/40 om page 6-12) the probe should be relocated after 4 hours at least.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523456-2014-00002 |
| MDR Report Key | 3879434 |
| Date Received | 2014-05-29 |
| Date of Report | 2014-05-02 |
| Date of Event | 2014-04-01 |
| Date Facility Aware | 2014-05-02 |
| Report Date | 2014-05-02 |
| Date Reported to FDA | 2014-05-29 |
| Date Reported to Mfgr | 2014-05-28 |
| Date Added to Maude | 2014-06-19 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 810 SHARON DR. |
| Manufacturer City | WESTLAKE OH 441451598 |
| Manufacturer Country | US |
| Manufacturer Postal | 441451598 |
| Manufacturer G1 | RADIOMETER AMERICA, INC. |
| Manufacturer Street | 810 SHARON DR. |
| Manufacturer City | WESTLAKE OH 44145159 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44145 1598 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSCUTANEOUS BLOOD GAS MONITOR |
| Generic Name | TCM4 MONITORING SYSTEM |
| Product Code | LKD |
| Date Received | 2014-05-29 |
| Model Number | TCM4 SERIES |
| Catalog Number | 391-880 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| 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 | 2014-05-29 |