MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-05-06 for COMPAX 40E XRA505 manufactured by Ge Medical Systems, Llc.
[1190940]
It was reported that the table locks did not actuate when the foot pedal was released, causing the tabletop to unexpectedly free float in the longitudinal and lateral directions. 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
[8523645]
The ge field engineer (fe) found that the unexpected float was caused by a loose plastic cover that prevented the foot pedal from reaching its resting position. This simulated a pedal activation which caused the locks to disengage and allow the tabletop to float. The fe reattached the cover and ensured that the pedal and table locks were functioning nominally.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2009-00033 |
| MDR Report Key | 1427944 |
| Report Source | 07 |
| Date Received | 2009-05-06 |
| Date of Report | 2009-01-15 |
| Date of Event | 2009-01-15 |
| Date Mfgr Received | 2009-01-15 |
| Date Added to Maude | 2009-09-21 |
| 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 | 3 |
| 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 | 2009-05-06 |
| Model Number | XRA505 |
| ID Number | SYSID PER42002 |
| 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 | WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-06 |