MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-04 for COMPACT 300 manufactured by Ge Medical Systems, Llc.
[82011234]
Ge healthcare's investigation is ongoing. A follow-up report will be submitted once the investigation has been completed. Due to country specific privacy laws, patient information is not available. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[82011235]
On (b)(6) 2017, the technologist at (b)(6) hospital in (b)(6) stated that during a wall stand chest radiographic exam using the compact 300 system, the collimator detached from the tube column. The collimator detached as the technologist was angulating for patient positioning. The collimator fell and struck the table and then fell to the floor. The collimator did not impact any person so there was no injury related to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-2017-00010 |
| MDR Report Key | 6767920 |
| Date Received | 2017-08-04 |
| Date of Report | 2017-10-18 |
| Date Mfgr Received | 2017-10-12 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2017-08-04 |
| 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 | BIOMEDICAL ENGINEER |
| 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 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COMPACT 300 |
| Generic Name | XR COMPACT300-MPS |
| Product Code | IZO |
| Date Received | 2017-08-04 |
| ID Number | UDI NOT REQUIRED |
| 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 | 2017-08-04 |