MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2014-11-15 for TRANSCUTANEOUS BLOOD GAS MONITOR TCM TOSCA/COMBIM 903-111 manufactured by Radiometer Medical Aps.
[16182919]
The tcm combim was reading too high when monitoring a pt. Readings were 80-90 mmhg and continued to go higher. As a consequence the patient (a pre-term infant) received treatment consisting in "bagging" to bring co2 down. It is stated in the complaint that there was no harm to the pt as result of the treatment. Later a blood sample from the pt was tested for co2 with result of 36 mmhg. At that time the tcm combim was reading 130 mmhg.
Patient Sequence No: 1, Text Type: D, B5
[16385270]
A simulator test has been performed with the combim monitor and the test was passed. The sensor electrode has been requested sent back to radiometer for investigation but it has not yet been received.
Patient Sequence No: 1, Text Type: N, H10
[74620945]
The sensor electrode was sent back to radiometer for investigation. The result of the investigation was that the sensor electrode was working as intended.
Patient Sequence No: 1, Text Type: N, H10
[74621010]
During an internal review of this case, it was discovered that the model and catalog number was stated incorrectly in the initial report and follow-up report no 1.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2014-00057 |
| MDR Report Key | 4260898 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-11-15 |
| Date of Report | 2016-10-14 |
| Date Mfgr Received | 2016-10-07 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2014-11-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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, 2720 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2720 |
| 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 | TRANSCUTANEOUS BLOOD GAS MONITOR |
| Generic Name | TCM TOSCA/COMBIM |
| Product Code | LKD |
| Date Received | 2014-11-15 |
| Returned To Mfg | 2014-08-01 |
| Model Number | TCM TOSCA/COMBIM |
| Catalog Number | 903-111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2014-11-15 |