MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-09-03 for TCM400 TCM400 BASE UNIT 391-880 manufactured by Radiometer Medical Aps.
[17342173]
Thursday, (b)(6) 2013, an operator switched off the mains switch of the analyzer and disconnected the line cord from the power outlet. During transport the operator wanted to make sure that it was the correct analyzer to ship for repair. While checking the serial number on the back of the monitor the operator's left forearm got in contact with the analyzer housing/ chassis. At the same time, he also got in contact with the male connector of the line cord and received an electrical shock. This happened 2 to 3 minutes after he disconnected the monitor from mains. The operator had visible marks on his left forearm and left ring finger from the electrical current flow, and was admitted for long term ecg monitoring for 24 hours. There was no further outcome for the patient except an occasional prickling in the affected arm.
Patient Sequence No: 1, Text Type: D, B5
[17549432]
The monitor has been returned for investigation. The error could not be re-constructed, but it was confirmed that the current event was not related to fan (b)(4) (3002807968-10/19/12-003-c initiated 2012-11-27). Further tests will be performed on the monitor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2013-00014 |
| MDR Report Key | 3330542 |
| Report Source | 01,05 |
| Date Received | 2013-09-03 |
| Date of Report | 2013-08-22 |
| Date of Event | 2013-08-15 |
| Date Mfgr Received | 2013-08-22 |
| Date Added to Maude | 2013-09-09 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCM400 |
| Generic Name | TCM400 |
| Product Code | LPP |
| Date Received | 2013-09-03 |
| Returned To Mfg | 2013-08-26 |
| Model Number | TCM400 BASE UNIT |
| Catalog Number | 391-880 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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. Hospitalization | 2013-09-03 |