MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-10-14 for COMPAX 40E manufactured by Ge Medical Systems, Llc.
[927128]
It was reported that the table locks would not actuate, causing unexpected bidirectional motion of the tabletop without resistance (free float). The issue was discovered during system power-up in preparation for an exposure. There was no injury reported. This situation could contribute to an injury if a pt or operator were unaware of this condition while loading a pt. The ensuing instability could lead to a fall.
Patient Sequence No: 1, Text Type: D, B5
[8100047]
The ge field engineer (fe) inspected that table and found a blown f12 fuse, causing all the table locks to disengage. The fe replaced the fuse and tested all functions of the table. The fe verified that the table locks were functional.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2008-00082 |
| MDR Report Key | 1198832 |
| Report Source | 07 |
| Date Received | 2008-10-14 |
| Date of Report | 2008-07-11 |
| Date of Event | 2008-07-11 |
| Date Mfgr Received | 2008-07-11 |
| Date Added to Maude | 2008-11-21 |
| 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 | 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 40E |
| Product Code | IZZ |
| Date Received | 2008-10-14 |
| ID Number | SYSTEM ID 919762DR4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1282202 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3000 N GRANDVIEW BLVD. WAUKESHA WI 53188 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-14 |