MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-05 for EMPOWER CTA/ EMPOWER CTA+ 87191 manufactured by Acist Medical Systems/bracco S.p.a..
[101839974]
Contrast injectors for ct scan failed during patient used: vendor: bracco-acist, injector name: empower cta (b)(4), serial # (b)(4); vendor: bracco-acist, injector name: empower cta (b)(4), serial # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075690 |
| MDR Report Key | 7316903 |
| Date Received | 2018-03-05 |
| Date of Report | 2018-03-01 |
| Date of Event | 2018-02-27 |
| Date Added to Maude | 2018-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EMPOWER CTA/ EMPOWER CTA+ |
| Generic Name | INJECTOR, CONTRAST MEDIUM |
| Product Code | IZQ |
| Date Received | 2018-03-05 |
| Model Number | 87191 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ACIST MEDICAL SYSTEMS/BRACCO S.P.A. |
| Brand Name | EMPOWER CTA/ EMPOWER CTA+ |
| Generic Name | INJECTOR, CONTRAST MEDIUM |
| Product Code | IZQ |
| Date Received | 2018-03-05 |
| Model Number | 87191 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACIST MEDICAL SYSTEMS/CRACCO S.P.A. |
| Brand Name | EMPOWER CTA/ EMPOWER CTA+ |
| Generic Name | INJECTOR, CONTRAST MEDIUM |
| Product Code | IZQ |
| Date Received | 2018-03-05 |
| Model Number | 87189 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ACIST MEDICAL SYSTEMS/CRACCO S.P.A. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-05 |