MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-10-15 for TCM40 391-880 manufactured by Radiometer Medical Aps..
[3083537]
A nurse have complained of receiving an electric shock from the mains plug pins after a tcm40 has been unplugged form the mains socket. The healthcare professional "experienced tingling in her arm and hand for 5 minutes" as a result of the electric shock. No medical intervention was needed. The tcm was investigated by the hospital's own medical electronic engineers and was found these to have over 100 vdc on the mains pins.
Patient Sequence No: 1, Text Type: D, B5
[10234823]
No pt medical intervention was needed. An evaluation is in-process and has not been completed. Once the evaluation has been completed a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2012-00010 |
| MDR Report Key | 2796359 |
| Report Source | 01,05 |
| Date Received | 2012-10-15 |
| Date of Report | 2012-09-14 |
| Date of Event | 2012-09-14 |
| Date Mfgr Received | 2012-09-14 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2013-01-29 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LASSE MOLLER, SPECIALIST |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Manufacturer Phone | 8273436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCM40 |
| Generic Name | TRANSCUTANEOUS BLOOD GAS MONITOR |
| Product Code | LKD |
| Date Received | 2012-10-15 |
| Model Number | TCM40 |
| 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 | BRONSHOJ DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-15 |