MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-12-16 for COMPAX 40E XRA003 manufactured by Ge Medical Systems, Llc.
[15911218]
It was reported that when the technologist was repositioning the tube of a compax 40e x-ray system after doing an ap upright view, the collimator detached and hit her on the wrist. A pt was on the table at the time but was not injured. There was no injury to the technologist as a result of the collimator impacting the wrist.
Patient Sequence No: 1, Text Type: D, B5
[16065675]
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
| Report Number | 2126677-2014-00025 |
| MDR Report Key | 4350569 |
| Report Source | 06 |
| Date Received | 2014-12-16 |
| Date of Report | 2014-11-17 |
| Date of Event | 2014-11-17 |
| Date Mfgr Received | 2014-11-17 |
| Device Manufacturer Date | 1993-04-01 |
| Date Added to Maude | 2014-12-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAUL CORRIGAN |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 4142130021 |
| Manufacturer G1 | GE MEDICAL SYSTEMS, LLC |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPAX 40E |
| Product Code | IZZ |
| Date Received | 2014-12-16 |
| Model Number | XRA003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | WAUKESHA WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-16 |