MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-10 for * TCM4 SERIES MKIII manufactured by Radiometer America, Inc..
[5760202]
Patient complained of burn on chest from sensor. Routine polysomnogram was performed with transcutaneous co2 monitoring. The following day, there was a burned spot about 6mm in diameter at the electrode site. ======================manufacturer response for transcutaneous co2 monitor, radiometer (per site reporter). ======================unit was sent to manufacturer for evaluation. All tests were within the acceptable range. The only problem was the need to replace the internal battery (not related to the incident). Log files and user reports indicate the sensor was left in the same spot for 8hrs. Instructions indicate the sensor should be moved every 4 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4612135 |
| MDR Report Key | 4612135 |
| Date Received | 2015-03-10 |
| Date of Report | 2015-03-10 |
| Date of Event | 2014-10-07 |
| Report Date | 2015-03-10 |
| Date Reported to FDA | 2015-03-10 |
| Date Reported to Mfgr | 2015-03-18 |
| Date Added to Maude | 2015-03-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | MONITOR, BLOOD GAS |
| Product Code | LKD |
| Date Received | 2015-03-10 |
| Returned To Mfg | 2014-10-20 |
| Model Number | TCM4 SERIES MKIII |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 7 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER AMERICA, INC. |
| Manufacturer Address | 810 SHARON DRIVE WESTLAKE OH 44145 US 44145 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-10 |