MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-03-10 for COMPAX 40E XRA505 manufactured by Ge Medical Systems, Llc.
[17719822]
It was reported at the site the table did not lock. 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
[17918381]
During inspection of the system, the ge field engineer (fe) could not reproduce the alleged malfunction. The fe found no evidence indicative of a device malfunction. The report indicated that the table did not lock. Additional information was not obtained from the site despite multiple attempts made by the fe. The information currently available thus far reasonably suggested movement of the tabletop without resistance in both lateral and longitudinal directions (free float).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2009-00016 |
| MDR Report Key | 1441636 |
| Report Source | 07 |
| Date Received | 2009-03-10 |
| Date of Report | 2009-02-09 |
| Date of Event | 2009-02-09 |
| Date Mfgr Received | 2009-02-09 |
| Date Added to Maude | 2010-05-21 |
| 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. 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 | 2009-03-10 |
| Model Number | XRA505 |
| ID Number | SYSID 956632COMPX |
| 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 | 2009-03-10 |