MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-04-30 for COMPAX 40E 2146726 NA manufactured by Ge Medical Systems, Llc.
[1266779]
It was reported that the wall stand bucky holder assembly fell from approximately 2 feet above the ground and contacted the floor. Prior to the incident, no patient was in the room and the technologist near the wall stand was setting up the assembly. When the technologist turned around, the assembly fell. There was no injury sustained as there was no contact with the technologist. Due to the weight of the assembly, the concern is for a serious injury if the assembly were to fall and contact a patient or technologist.
Patient Sequence No: 1, Text Type: D, B5
[8271294]
The assembly is mounted by small metric screws on the top and bottom of the bucky tray assembly. During inspection, the ge field engineer (fe) found that the mounting screws at the bottom of the assembly had come loose and broke. The fe also inspected the assembly and found that the bottom trim cover was damaged as a result of the fall. The fe replaced both the bottom trim cover and the mounting screws.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2009-00031 |
| MDR Report Key | 1426096 |
| Report Source | 05 |
| Date Received | 2009-04-30 |
| Date of Report | 2009-04-01 |
| Date of Event | 2009-03-30 |
| Date Mfgr Received | 2009-04-01 |
| Device Manufacturer Date | 1997-04-01 |
| Date Added to Maude | 2009-09-09 |
| 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. W450 |
| 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 | 2009-04-30 |
| Model Number | 2146726 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | OTHER |
| 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 | 2009-04-30 |