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 2014-11-07 for TRANSCUTANEOUS BLOOD GAS MONITOR TCM4 SERIES 391-880 manufactured by Radiometer Medical Aps.
[4988519]
According to the complaint two patients received skin blisters after using the tcm4 for a sleep study. Two tcm4 monitors were sent to radiometer for evaluation but the customer did not know which of the two monitors were used for the study. This report concerns patient ref (b)(6). Mdr reports for the other affected patient will be submitted with mdr reference 3002807968-2014-00054.
Patient Sequence No: 1, Text Type: D, B5
[12550622]
Both units have been received and tested by radiometer. The units needed new batteries but apart from this all tests were passed. The sensor temperature was set to 43 degrees on both units and the site time was set to 10 hrs on one unit (b)(4) and 4 hrs on the other (b)(4). The sensor temperature was changed to 42 degrees c and the site time to 4 hrs before returning the units to the customer. According to the customer the user has received proper training and the operators manual was followed. This injury is evaluated as reportable, but based on the information 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 | 3002807968-2014-00055 |
| MDR Report Key | 4255671 |
| Report Source | 05,06,07 |
| Date Received | 2014-11-07 |
| Date of Report | 2014-10-08 |
| Date Mfgr Received | 2014-10-08 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2014-11-19 |
| 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 Postal | DK-2700 |
| Manufacturer Phone | 8273216 |
| 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 | 2014-11-07 |
| 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 | 2014-11-07 |