MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-04-22 for DEFINIUM 8000 5131070 NA manufactured by Ge Medical Systems, Llc.
[1114910]
It was reported that the table locks disengaged without foot pedal activation, causing an unexpected free float motion of the tabletop in the longitudinal and lateral directions. The site indicated that the float occurred as the table was lowered to its lowest setting. There was no pt involvement and no injury reported. This situation 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.
Patient Sequence No: 1, Text Type: D, B5
[8351623]
Ge field engineer (fe) found that the foot pedal mechanism was not aligned properly. The fe readjusted the pedal and verified the table locks were performing as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2009-00029 |
| MDR Report Key | 1424813 |
| Report Source | 05 |
| Date Received | 2009-04-22 |
| Date of Report | 2009-03-23 |
| Date of Event | 2009-03-20 |
| Date Mfgr Received | 2009-03-23 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2009-08-28 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| 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 | DEFINIUM 8000 |
| Generic Name | KPR/IZF/MQB |
| Product Code | IZZ |
| Date Received | 2009-04-22 |
| Model Number | 5131070 |
| 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 | 2009-04-22 |