MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-12-08 for COMPAX 40E 2225881 NA manufactured by Ge Medical Systems, Llc..
[1045518]
It was reported that the collimator weighing approximately 40lbs detached and fell from the x-ray tube assembly, while the technologist was positioning the tube from a horizontal to an angled position. The technologist was able to catch the collimator before it fell to the table. No injury was reported. The concern is for a serious injury, if the collimator were to fall and contact a patient or operator due to its weight.
Patient Sequence No: 1, Text Type: D, B5
[8205282]
Ge field engineer found that the bolts that hold the collimator plate to the tube became loose, allowing the collimator to detach and fall from the x-ray tube assembly. Visual inspection of the collimator revealed no damage obtained during the drop. The fe re-installed the collimator in accordance to the service manual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2008-00102 |
| MDR Report Key | 1296298 |
| Report Source | 05 |
| Date Received | 2008-12-08 |
| Date of Report | 2008-10-09 |
| Date of Event | 2008-10-09 |
| Date Mfgr Received | 2008-10-09 |
| Device Manufacturer Date | 2000-12-01 |
| Date Added to Maude | 2009-05-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARTHA KAMROW |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2623127196 |
| Manufacturer G1 | GE MEDICAL SYSTEMS, LLC. |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53188 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPAX 40E |
| Product Code | IZZ |
| Date Received | 2008-12-08 |
| Model Number | 2225881 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2008-12-08 |