MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-24 for EMPOWER MR * 102901 manufactured by Acist Medical Systems, Inc..
[4580831]
Mri technician just finished power injecting the patient with contrast. The patient was not holding his breath well so she went into the room to talk with him. He was visibly struggling to breathe and was blue in color. A code was called and the patient died shortly thereafter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3925148 |
| MDR Report Key | 3925148 |
| Date Received | 2014-06-24 |
| Date of Report | 2014-06-24 |
| Date of Event | 2014-06-22 |
| Report Date | 2014-06-24 |
| Date Reported to FDA | 2014-06-24 |
| Date Reported to Mfgr | 2014-07-10 |
| Date Added to Maude | 2014-07-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMPOWER MR |
| Generic Name | INJECTOR AND SYRINGE, ANGIOGRAPHIC |
| Product Code | IZQ |
| Date Received | 2014-06-24 |
| Returned To Mfg | 2014-06-24 |
| Model Number | * |
| Catalog Number | 102901 |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 2 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 7450 FLYING CLOUD DRIVE EDEN PRAIRIE MN 55344 US 55344 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-06-24 |