MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-07-20 for TC SENSOR 54, PCO2 945-736 manufactured by Radiometer Medical Aps.
[49945643]
According to the complaint, an electrode burned a baby, resulting in a blister. The incident occured during a sleep study. The mother waited one week after the sleep study to report the incident to the hospital. No treatment was needed. According to the complaint, the sensor was applied for approximately 7 hours at 44 degrees. The instructions for use state that for patients aged up to (b)(6), the maximum sensor-skin interface temperature is 42 degrees celsius with a recommended maximum application time of up to 12 hours. The instructions for use state that the recommended maximum application time at 44 degrees celsius (for patients older than (b)(6) is 4 hours. Hence, the incident is caused a user error of the device.
Patient Sequence No: 1, Text Type: D, B5
[56470167]
This instrument was checked out by our trained field service engineer at facility. Base unit, module and electrode were checked out and all passed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2016-00021 |
| MDR Report Key | 5807962 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-07-20 |
| Date of Report | 2016-10-05 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2016-09-06 |
| Date Added to Maude | 2016-07-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KRISTINA TOFT |
| Manufacturer Street | AAKANDEVEJ 21 |
| Manufacturer City | BROENSHOEJ, DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2700 |
| Manufacturer Phone | 538273349 |
| Manufacturer G1 | RADIOMETER MEDICAL APS |
| Manufacturer Street | AAKANDEVEJ 21 |
| Manufacturer City | BROENSHOEJ, DK-2700 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK-2700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TC SENSOR 54, PCO2 |
| Generic Name | TC SENSOR 54, PCO2 |
| Product Code | LKD |
| Date Received | 2016-07-20 |
| Catalog Number | 945-736 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AAKANDEVEJ 21 BROENSHOEJ, BROENSHOEJ DK-2700 DA DK-2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-20 |