MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-08-13 for TRANSCUTANEOUS BLOOD GAS MONITOR manufactured by Radiometer Medical Aps.
[5284269]
According to the complaint, a (b)(6) year old child received a small abrasion/skin reaction or burn on the arm after using the tcm4 for a sleep study. After a week it was still not healed. More info, including a picture of the injury, has been requested in order to further specify the type of injury.
Patient Sequence No: 1, Text Type: D, B5
[12654198]
The monitor has been received and tested by radiometer and all tests were passed. The following warning is included in the operators manual p 6-2: "warning-risk of burns: do not allow the tcpco2/tcpo2 sensor temperature to exceed 43 degrees celsius for neonates and 44 degrees celsius for adults if sensors are attached to skin for more than four hours as this may otherwise cause burns. The temperature of the sensor was 43 degrees celsius. Info regarding how long the sensor was attached to the skin has been requested to determine if and if this event could be caused by a user error. It was mentioned in the complaint that the patient rolled onto the side where the sensor was attached. This could enhance the heating effect of the sensor. No info of treatment applied has been received. This injury is evaluated as reportable, but based on the info currently available 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 | 3002807968-2014-00033 |
| MDR Report Key | 4375994 |
| Report Source | 05,06,07 |
| Date Received | 2014-08-13 |
| Date Mfgr Received | 2014-07-14 |
| Date Added to Maude | 2015-01-02 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 | TCM4 MONITORING SYSTEM |
| Product Code | LKD |
| Date Received | 2014-08-13 |
| 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 | 2014-08-13 |