MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-21 for GE HEALTHCARE * 85618 manufactured by Ge Healthcare.
[1634486]
The pt was taken to the extracorporeal shock wave lithotripsy (eswl) room by the circulator and the anesthesiologist. Upon entering the room, the circulator noted the eswl leaking clear fluid onto the floor. The eswl tech was notified. The dr and the circulator returned the pt to the preoperative area. The safety measures were maintained. The dr was notified of the eswl table and the md made the decision to abort the case. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1741217 |
| MDR Report Key | 1741217 |
| Date Received | 2010-05-21 |
| Date of Report | 2010-05-21 |
| Date of Event | 2010-03-03 |
| Report Date | 2010-05-21 |
| Date Reported to FDA | 2010-05-21 |
| Date Added to Maude | 2010-06-29 |
| 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 | 0 |
| 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 | GE HEALTHCARE |
| Generic Name | LITHOTRIPTER, GALLSTONE |
| Product Code | NCV |
| Date Received | 2010-05-21 |
| Model Number | * |
| Catalog Number | 85618 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | * SUN VALLEY 800-660- CA * US * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-21 |