MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-07 for TRANSCUTANEOUS BLOOD GAS MONITOR TCM4 SERIES 391-880 manufactured by Radiometer Medical Aps.
[5178719]
According to the complaint two patients received skin blisters after using the tcm4 for a sleep study. Two tcm4 monitors was 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 (b)(4). Mdr reports for the other affected patient will be submitted with mdr reference 3002807968-2014-00054.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523456-2014-00008 |
| MDR Report Key | 4356208 |
| Date Received | 2014-11-07 |
| Date of Report | 2014-10-08 |
| Date Facility Aware | 2014-10-08 |
| Report Date | 2014-11-06 |
| Date Reported to FDA | 2014-11-07 |
| Date Reported to Mfgr | 2014-10-08 |
| Date Added to Maude | 2014-12-29 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 810 SHARON DR. |
| Manufacturer City | WESTLAKE OH 441451598 |
| Manufacturer Country | US |
| Manufacturer Postal | 441451598 |
| Manufacturer G1 | RADIOMETER AMERICA, INC. |
| Manufacturer Street | 810 SHARON DR. |
| Manufacturer City | WESTLAKE OH 44145159 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44145 1598 |
| Single Use | 0 |
| Previous Use Code | 0 |
| 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 | 5 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AKANDEJEV 21 BRONSHOJ DK-2700 DA DK-2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-07 |