MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-12-16 for COMPAX 40E manufactured by Ge Medical Systems, Llc.
[1019693]
It was reported that the table locks did not actuate when the foot pedal was released as the pt was being prepared for an exam, causing unexpected lateral motion of the tabletop without resistance (lateral 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 a pt. The ensuing instability could lead to a fall.
Patient Sequence No: 1, Text Type: D, B5
[8135807]
Upon discovery of the unexpected lateral float, the site was still able to use the table for the exam when they used the redundant mechanical interlock to inhibit lateral motion. The ge field engineer (fe) evaluated the system and found a damaged microswitch. The fe replaced the microswitch and verified that the table locks were performing according to specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2008-00104 |
| MDR Report Key | 1265724 |
| Report Source | 06 |
| Date Received | 2008-12-16 |
| Date of Report | 2008-10-22 |
| Date of Event | 2008-10-22 |
| Date Mfgr Received | 2008-10-22 |
| Date Added to Maude | 2009-11-19 |
| 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 | 2008-12-16 |
| ID Number | SYSTEMID 918682MX5 |
| 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 | 2008-12-16 |