MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-13 for CONTRAST MEDIA INJECTOR STELLANT manufactured by Medrad.
[6056142]
This incident pertains to the medrad injector model sellant under (b)(4) use at (b)(6) healthcare system, (b)(6). Unit is currently under preventive maintenance with precise biomedical and the discovery of this issue was during the scheduled routine maintenance which was done on (b)(6) 2015. Precise biomedical field service engineer found out that the ethernet cable connector was not properly secured and soldered on the electronic board. A precise work order number (b)(6) dated (b)(6) 2015 documented the findings as well as (b)(6) work order at (b)(6). (b)(6) reported this matter to medrad under reference number (b)(4). System was repaired by (b)(6) to manufacturers specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5044409 |
| MDR Report Key | 4924481 |
| Date Received | 2015-07-13 |
| Date of Report | 2015-07-13 |
| Date of Event | 2015-06-23 |
| Date Added to Maude | 2015-07-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTRAST MEDIA INJECTOR |
| Generic Name | CONTRAST MEDIA INJECTOR |
| Product Code | IZQ |
| Date Received | 2015-07-13 |
| Model Number | STELLANT |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDRAD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-13 |