MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-30 for COMPAX 40E 46-216697P3 NA manufactured by Ge Medical Systems, Llc.
[15184179]
It was reported that the table locks did not actuate when the foot pedal was released, causing the tabletop to unexpectedly move without resistance in both longitudinal and lateral directions (free float). The incident was observed while after a patient was loaded onto the table. 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
[15732038]
According to the report, the chief technologist said the lock pedal area was cleaned after the event to remove any foreign material that may have been interfering with the pedal motion. The ge field engineer inspected the table lock mechanism and pedal area and was able to remove some debris from the pedal areas, but was not able to reproduce the problem, but felt debris was the most likely cause. He tested the table operations, found no other problems and returned the room to the customer for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2009-00020 |
| MDR Report Key | 1418554 |
| Report Source | 05 |
| Date Received | 2009-03-30 |
| Date of Report | 2009-03-03 |
| Date of Event | 2009-03-02 |
| Date Mfgr Received | 2009-03-03 |
| Date Added to Maude | 2010-02-16 |
| 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. 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 | 2009-03-30 |
| Model Number | 46-216697P3 |
| 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 | 2009-03-30 |