MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-10-08 for COMPAX 40E 45434237 NA manufactured by Ge Medical Systems, Llc.
[926898]
It was reported that the tabletop unexpected moved bidirectionally without resistance (free float) during loading of a pt. The technologist had to prop the table to stabilize it for the pt. After the pt was removed from the table, it was reported that the locks were functioning properly. There was no report that the pt fell nor an injury occurred. The unexpected float could contribute to an injury if a pt or operator were unaware of this condition while loading or unloading a pt. The ensuing instability could lead to a fall. During an interview with the ge field engineer, the technologist indicated that she was not aware of the mechanical interlock feature of the table to restrict the motion in the lateral direction.
Patient Sequence No: 1, Text Type: D, B5
[8099571]
During eval of the system, the field engineer (fe) was unable to duplicate the problem. The fe verified that the table was functioning according to specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2008-00078 |
| MDR Report Key | 1196979 |
| Report Source | 05 |
| Date Received | 2008-10-08 |
| Date of Report | 2008-09-12 |
| Date of Event | 2008-09-08 |
| Date Mfgr Received | 2008-09-12 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 2009-03-16 |
| 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 | 2008-10-08 |
| Model Number | 45434237 |
| 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 | 2008-10-08 |