MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-02-26 for COMPAX 40E 2225864 NA manufactured by Ge Medical Systems, Llc.
[1074075]
It was reported the table locks did not actuate, causing the tabletop to unexpectedly move in both 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
[8186846]
Preliminary inspection performed by the ge field engineer (fe) revealed that the alleged float was caused by power loss to the table locks due to a blown fuse. The fe replaced the fuse, but it was reported that the power loss reoccurred the next day. Further investigation showed that the left table horizontal lock was loose. Hardware had fallen out and the lock was moving around and was intermittently shorting out against terminal strip, hence blowing the fuse. The fe fastened the lock back into place and verified that the reported issue did not recur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2009-00011 |
| MDR Report Key | 1334720 |
| Report Source | 05 |
| Date Received | 2009-02-26 |
| Date of Report | 2009-02-01 |
| Date of Event | 2009-02-01 |
| Date Mfgr Received | 2009-02-01 |
| Device Manufacturer Date | 1999-04-01 |
| Date Added to Maude | 2009-12-18 |
| 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 | 2009-02-26 |
| Model Number | 2225864 |
| 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 | 2009-02-26 |