MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-11-28 for TCM TCM4 391-878 manufactured by Radiometer Medical Aps.
[772130]
While monitored by a transcutaneous monitoring device, a study patient suffered a burn on his chest. The 2 mm blister was treated with ointment as a "moderate" burn. We have only little info about the event and the burn as the customer has been reluctant to provide answers to several info requests. It is therefore, assumed that the burn constitutes a second degree burn. The customer has provided info that reveal that they know they have left the electrode on the same site for a longer period than described in the operator's manual. The hosp admitted that they should have moved the electrodes every 4 hours.
Patient Sequence No: 1, Text Type: D, B5
[8117670]
Warning in the operator's manual says: do not allow the tcpo2/tcpco2 electrode temperature to exceed 43 degree c for neonates and 44 degree c for adults if electrodes are attached to skin for more than four hours. Tcpo2/tcpco2 electrode and reusable spo2 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 electrode/sensor placement, it may be necessary to change the electrode/sensor site more frequently with some patients. If skin integrity changes, move the electrode/sensor to another site. The combination of temperature setting and time of exposure leading to this event has already been addressed in the risk analysis for the product. Mitigation has been implemented in form of the above mentioned warning in the operator's manual (see details above) under preliminary analysis. We have searched our current complaint database going back to 2004 for similar incidents and only found one. Therefore we consider the warning in our operator's manual to be appropriate and the result of our risk analysis still to be valid.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2007-00015 |
| MDR Report Key | 954255 |
| Report Source | 05,06 |
| Date Received | 2007-11-28 |
| Date of Report | 2007-11-23 |
| Date of Event | 2007-11-09 |
| Date Added to Maude | 2007-12-03 |
| 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 | 3 |
| Manufacturer Contact | GERT NIELSEN |
| Manufacturer Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Manufacturer Phone | 8273057 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCM |
| Generic Name | TCM4 |
| Product Code | KLK |
| Date Received | 2007-11-28 |
| Model Number | TCM4 |
| Catalog Number | 391-878 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 926715 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | BROENSHOEJ (COPENHAGEN) DA DK-27000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2007-11-28 |