MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-29 for TRANSCUTANEOUS BLOOD GAS MONITOR TCM4 SERIES 391-880 manufactured by Radiometer Medical Aps.
[4462349]
The pt (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
[12082791]
According to the complaint the temp of the sensor was set to 43 degrees celsius and the sensor was placed on the same location for 7 hrs. According to the operator's manual (tcm4/40 om page 6-12) the probe should be relocated after 4 hrs at least. A zero check on the sensor was performed and it passed fine. The temp was stable at 42. 9 celsius so it was not an issue with the sensor. Additionally, the field service engineer completed the tcm4 complete alignment, and monitor performance test and everything passed fine. Since no error was identified on the unit or sensor, and it was stated that the sensor was not relocated every 4 hrs as it should be this case is suspected to be caused by a user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2014-00017 |
| MDR Report Key | 3874109 |
| Report Source | 05 |
| Date Received | 2014-05-29 |
| Date of Report | 2014-05-02 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2014-05-02 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2014-06-17 |
| 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 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSCUTANEOUS BLOOD GAS MONITOR |
| Generic Name | TCM4 MONITORING SYS |
| Product Code | LKD |
| Date Received | 2014-05-29 |
| Model Number | TCM4 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 2700 DA 2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-29 |