MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-02 for RFX/SFX manufactured by Ge Medical Systems, Llc.
[81805107]
Ge healthcare's investigation is ongoing. A follow-up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[81805110]
On (b)(6)2017, the technologist at (b)(6) in the united states reported they heard a loud noise that came from the radiology exam room. When the technologist investigated the noise, they identified the crt monitor detached from the monitor suspension and was hanging from the suspension by the power cables. There was nobody within the exam room when the monitor fell and there was no injury related to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-2017-00009 |
| MDR Report Key | 6761696 |
| Date Received | 2017-08-02 |
| Date of Report | 2017-10-20 |
| Date Mfgr Received | 2017-10-05 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2017-08-02 |
| 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 | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNE KRUEGER |
| Manufacturer Street | 3000 NORTH GRANDVIEW BOULEVARD |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 3007734888-12/01/16-001C |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RFX/SFX |
| Generic Name | TABLE, X-RAY, RFX CLASSICAL |
| Product Code | IXR |
| Date Received | 2017-08-02 |
| ID Number | UDI NOT REQUIRED |
| Operator | HEALTH PROFESSIONAL |
| 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 NORTH GRANDVIEW BOULEVARD WAUKESHA, WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-02 |