MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-07-21 for TRANSCUTANEOUS BLOOD GAS MONITOR TCM4 SERIES 391-880 manufactured by Radiometer Medical Aps.
[16178734]
According to the complaint skin blisters were received after using the tcm4 sensor for 9 hours at the same location with the temperature set at 45 degrees. Ten patients were affected. Currently, the patient information received for all patients is identical. More information has been requested. This report regards patient number 7. Mdr reports for the affected patients will be submitted with mdr reference 302807968-2014-00023 to 3002807968-2014-00032.
Patient Sequence No: 1, Text Type: D, B5
[16317169]
The electrode has been requested back for investigation to determine if this problem has been caused by a product malfunction or a user error. Based on the event description this case could be caused by a user error since the electrode temperature was set higher than recommended and for 9 hours instead of only 4 hours. It will be determined if tis event was caused by a product malfunction or a user error when the electrode has been investigated. Based on the pictures received the blisters are evaluated to be 2nd degree burn marks. This injury is evaluated as reportable, but the injury is only evaluated as minor as it does not meet the criteria of a serious injury, as described in the instructions for this form.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2014-00029 |
| MDR Report Key | 3976214 |
| Report Source | 01,05,07 |
| Date Received | 2014-07-21 |
| Date of Report | 2014-06-26 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-05-02 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2014-08-05 |
| 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 |
| Manufacturer Country | DA |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSCUTANEOUS BLOOD GAS MONITOR |
| Generic Name | TCM4 MONITORING SYSTEM |
| Product Code | LKD |
| Date Received | 2014-07-21 |
| 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 DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-21 |