MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-22 for PRECISION 500D R&F X-RAY SYSTEM 2290800 manufactured by Ge Medical Systems, Llc.
[145779682]
A ge healthcare investigation has been initiated and is ongoing. A follow-up mdr will be provided when ge healthcare's investigation has been completed. Although requested, the user was unable to provide patient information. Although requested, the user was unable to provide the incident date. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[145779683]
During a periodic maintenance inspection being performed on (b)(6) 2019 at riverside healthcare in the united states, the ge field engineer (fe) was notified that a patient had fallen off their precision 500d system¿? S table and was injured. The customer reported that during an exam while waiting for time to elapse to continue with the procedure, the patient had fallen asleep while lying on the table. While they were asleep, they fell from the table and received a broken toe. The customer did not provide any further details of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-2019-00005 |
| MDR Report Key | 8631846 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-22 |
| Date of Report | 2019-07-03 |
| Date Mfgr Received | 2019-06-17 |
| Device Manufacturer Date | 2015-11-02 |
| Date Added to Maude | 2019-05-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEVEN WALCZAK |
| Manufacturer Street | 3000 NORTH GRANDVIEW BOULEVARD |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISION 500D R&F X-RAY SYSTEM |
| Generic Name | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I |
| Product Code | JAA |
| Date Received | 2019-05-22 |
| Model Number | 2290800 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3000 N GRANDVIEW BLVD. WAUKESHA, WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-22 |