MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-22 for GAMMA CAMERA INFINIA HAWKEYE manufactured by Ge Healthcare.
[20454448]
On (b)(6) 2014, a pt was lifted off of the ge infinia hawkeye table onto a gurney and wheeled out of the room. The tech pushed the "unload" button to set the table up for the next pt and walked out of the room. When the table was fully lowered, it tipped over and fell over its side. A staff member said that he saw the table fall over slowly and there was no objects around the table. There was no pt or staff injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5035783 |
| MDR Report Key | 3775725 |
| Date Received | 2014-04-22 |
| Date of Report | 2014-04-21 |
| Date of Event | 2014-04-14 |
| Date Added to Maude | 2014-04-29 |
| 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 | 3 |
| Health Professional | 3 |
| 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 | GAMMA CAMERA |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2014-04-22 |
| Model Number | INFINIA HAWKEYE |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-22 |