MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-12 for COMPAX 40E XRA506 manufactured by Ge Medical Systems, Llc.
[1130036]
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). The condition occurred while a pt was on the table. There was no report of a fall or injury. This situation could contribute to an injury if a pt or operator were unaware of this condition while loading or unloading a pt. The ensuring instability could lead to a fall.
Patient Sequence No: 1, Text Type: D, B5
[8333047]
The ge field engineer (fe) evaluated the system and found that the unexpected free float was due to power loss to the table locks. After investigation, the fe determined that a blown 15a fuse caused the power loss. The fe replaced the fuse and verified that the table locks were performing as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2009-00018 |
| MDR Report Key | 1395128 |
| Report Source | 05 |
| Date Received | 2009-03-12 |
| Date of Report | 2009-02-19 |
| Date of Event | 2009-02-18 |
| Date Mfgr Received | 2009-02-19 |
| Date Added to Maude | 2009-09-04 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2009-03-12 |
| Model Number | XRA506 |
| ID Number | SYSID 605747MPH |
| 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 | 2009-03-12 |