MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-04-11 for TRANSCUTANEOUS BLOOD GAS MONITOR TCM4 SERIES 391-880 manufactured by Radiometer Medical Aps.
[4551074]
The patient rec'd a second degree burn mark on the arm, after the tc sensor was removed. The temperature was set to 43 degrees celsius, and the electrode was placed on the same location for 60 minutes. According to the doctor, the patient was going through a septic shock, and this can lead to decreased blood circulation.
Patient Sequence No: 1, Text Type: D, B5
[11866561]
According to the complaint, the temperature of the sensor was set to 43 degrees celsius and the sensor was relocated every 60 minutes. This is within the operator's manual for patients with normal blood circulation. However, in the operators manual there is a warning about always paying attention to the use of the sensors on patients in shock due to risk of skin damage. Warning - risk of skin damage. Long-term hyperthermia may blister skin. When producing local hyperemia by means of hyperthermia, a certain risk of applying temperatures harmful to the skin is always present, although the risk is limited due to the control system of the instrument. Always pay attention to the use of hyperthermia for special patients - e. G. Patients in shock, patients with low blood pressure, and patients with vascular constrictions. The placement of the sensor for 60 minutes could explain the burn mark on this patient. To analyze the case further the sensor will be investigated to see if a product malfunction also contributed to this case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2014-00014 |
| MDR Report Key | 3760957 |
| Report Source | 01,05 |
| Date Received | 2014-04-11 |
| Date of Report | 2014-03-12 |
| Date of Event | 2014-03-08 |
| Date Mfgr Received | 2014-03-12 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2014-04-22 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSCUTANEOUS BLOOD GAS MONITOR |
| Generic Name | TCM TOSCA COMBI M |
| Product Code | LKD |
| Date Received | 2014-04-11 |
| 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 DK-2700 DA DK-2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-11 |