MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-11-12 for COMPAX 40E 45435245 NA manufactured by Ge Medical Systems, Llc.
[994649]
It was reported that the table locks did not actuate, causing the tabletop to unexpectedly move in the longitudinal and lateral directions without resistance (free float). There was no injury reported. This situation could contribute to an injury if a patient or operator were unaware of this condition while loading or unloading a patient. The ensuing instability could lead to a fall.
Patient Sequence No: 1, Text Type: D, B5
[8134838]
The ge field engineer (fe) was dispatched to the site and found that screws fell out of the bucky tray and shorted the table's circuit breaker, interrupting the power supplied to the table locks. The site contact reported to the fe that the table floated in the longitudinal axis only. The fe visited the site again to confirm the longitudinal float, but found that the table would float in both longitudinal and lateral axes when there was a loss of power to the table locks.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2008-00091 |
| MDR Report Key | 1235629 |
| Report Source | 07 |
| Date Received | 2008-11-12 |
| Date of Report | 2008-10-06 |
| Date of Event | 2008-10-06 |
| Date Mfgr Received | 2008-11-06 |
| Device Manufacturer Date | 1994-09-01 |
| Date Added to Maude | 2009-06-29 |
| 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. W709 |
| 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 | 2008-11-12 |
| Model Number | 45435245 |
| 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 | 2008-11-12 |