MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-10-08 for COMPAX 400 manufactured by Ge Medical Systems, Llc.
[926974]
It was reported that the table locks did not actuate, causing the tabletop to unexpectedly move in both lateral and longitudinal directions without resistance (free float). There was 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
[8198941]
The ge field engineer (fe) found that the foot pedal was out of adjustment that caused the switches to stay activated. Consequently, the pedal mechanism continuously sent the float command, preventing the locks from engaging. A second fe was dispatched to the site to repair the system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2008-00079 |
| MDR Report Key | 1196978 |
| Report Source | 07 |
| Date Received | 2008-10-08 |
| Date of Report | 2008-04-29 |
| Date of Event | 2008-04-29 |
| Date Mfgr Received | 2008-04-29 |
| Date Added to Maude | 2009-09-14 |
| 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 |
| 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 | COMPAX 400 |
| Product Code | IZZ |
| Date Received | 2008-10-08 |
| ID Number | SYSTEMID UE148607 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2008-10-08 |