MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-06-22 for COMPACT 300 manufactured by Ge Medical Systems, Llc.
[112052203]
A ge healthcare investigation has been initiated. A follow-up report will be submitted once the investigation has been completed. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[112052204]
On (b)(6) 2018, the technologist at (b)(6) was injured while inserting a cassette into the cassette tray of their compact 300 system. The technologist positioned their left hand fingers underneath the locking latch while positioning the cassette into place when the latch of the cassette tray released. The technologist attempted to quickly remove their hand but their left hand forth digit was pinched in the latch mechanism. The technologist received an x-ray and was diagnosed with a fractured finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-2018-00012 |
| MDR Report Key | 7630212 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-22 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-05-29 |
| Date Mfgr Received | 2018-10-12 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2018-06-22 |
| 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 | 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPACT 300 |
| Generic Name | COMPACT300-MPS50 |
| Product Code | IZO |
| Date Received | 2018-06-22 |
| 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 | 1. Required No Informationntervention | 2018-06-22 |