MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-04 for TCM COMBIM 903-111 manufactured by Radiometer Medical Aps.
[27591649]
The analyzer was taken to radiometers workshop and it was upgraded with a newer pc/mother board, combim modul 903-111, and a new cf card 933-269. The error did not appear after replacement of above named parts and the analyzer has been shipped back to the customer site.
Patient Sequence No: 1, Text Type: N, H10
[69595505]
Not fei based: the mdr report for this case is not fei based for follow up report no. 1. The mdr report no. Was missing the digits 968 and stated to be 3002807-2015-00022 instead of 3002807968-2015-00022. Date of this report: was left blank in follow up 1 (10/06/2015).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2015-00022 |
| MDR Report Key | 5061907 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-09-04 |
| Date of Report | 2017-03-10 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2017-02-28 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2015-09-08 |
| 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 Street | AKANDEVEJ 21 |
| Manufacturer City | BRONSHOJ |
| Manufacturer Country | DA |
| Manufacturer Phone | 8273349 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCM COMBIM |
| Product Code | LKD |
| Date Received | 2015-09-04 |
| Returned To Mfg | 2015-08-25 |
| Model Number | 903-111 |
| Catalog Number | 903-111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | 2700 BRONSJOJ BRONSHOJ DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-04 |