MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-01-11 for COMPAX 400 46-909330G01 NA manufactured by Ge Medical Systems S.c.s..
[15627835]
It was reported that the table locks were not actuating when the foot pedal was released, causing the tabletop unexpectedly move in both longitudinal and lateral directions without resistance (free float). The issue was discovered during set-up. There was no injury reported. This situation could contributed to an injury if a patient or operator were unaware of this condition while loading or unloading a patient. The ensuring instability could lead to a fall.
Patient Sequence No: 1, Text Type: D, B5
[15986404]
Ge field engineer (fe) found that the unexpected float was due to loss of power to the table locks. The power loss was caused by a broken cable. The fe replaced the cable and verified that the table locks were performing according to specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611343-2009-00007 |
| MDR Report Key | 1311013 |
| Report Source | 06 |
| Date Received | 2009-01-11 |
| Date of Report | 2008-11-04 |
| Date of Event | 2008-11-04 |
| Date Mfgr Received | 2008-11-04 |
| Device Manufacturer Date | 1993-02-01 |
| Date Added to Maude | 2009-12-14 |
| 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 | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARTHA KAMROW |
| Manufacturer Street | 3000 N.GRANDVIEW BLVD. W709 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2623127196 |
| Manufacturer G1 | GE MEDICAL SYSTEMS S.C.S. |
| Manufacturer Street | 283, RUE DE LA MINIERE, BP-34 |
| Manufacturer City | BUC CEDEX 78533 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 78533 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPAX 400 |
| Product Code | IZZ |
| Date Received | 2009-01-11 |
| Model Number | 46-909330G01 |
| 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 S.C.S. |
| Manufacturer Address | 283, RUE DE LA MINIERE BP-34 BUC CEDEX 78533 FR 78533 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-11 |