MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-05-17 for TRANSCUTANEOUS BLOOD GAS MONITOR TCM4 391-880 manufactured by Radiometer Medical Aps.
[3565667]
The pt rec'd a blistering burn mark on the left upper chest, lateral to the sternum. When removing the probe from the burn site a layer of skin came off. The site was sensitive to touch and a 'polysporin' ointment was applied to the affected skin area. The area was sensitive after removal of the probe. The pt was diagnosed with sleep apnea, had no allergies, was non-smoker and non-alcohol user, and was using 'desogestrel', a hormonal contraceptive.
Patient Sequence No: 1, Text Type: D, B5
[10743981]
The user left the electrode probe on the skin for 6 hrs, with a temperature of 44 degrees c. The recommended temperature setting is 43 degrees c, and the ifu includes the following warning: "warning - risk of skin damage: sensors must be moved to a new site at least every four hrs. Because individual skin condition affects the ability of the skin to tolerate sensor placement, it may be necessary to change the sensor site more frequently with some pts. If skin integrity changes, move the sensor to another site. " monitor and electrode were rec'd back to the importer for testing. An alignment test showed that the monitor is functioning as normal.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2013-00009 |
| MDR Report Key | 3122668 |
| Report Source | 01,05 |
| Date Received | 2013-05-17 |
| Date of Report | 2013-04-16 |
| Date of Event | 2013-04-16 |
| Date Mfgr Received | 2013-04-16 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2013-05-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LASSE POST MOLLER, RA SPECIALIS |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSCUTANEOUS BLOOD GAS MONITOR |
| Generic Name | TCM4 |
| Product Code | LKD |
| Date Received | 2013-05-17 |
| Model Number | TCM4 |
| Catalog Number | 391-880 |
| ID Number | ELECTRODE 5280-JH09 |
| 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 | 2013-05-17 |