MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2009-01-07 for ARM + BRACKET ASSY CT9000ADV 241047 manufactured by Liebel - Flarsheim Co..
[997755]
Customer reports: the injector arm broke at the last pivot. There was a patient on the scan table, the patient was mostly in the gantry. The patient was not connected to the injector yet. When the technician went to move the injector, the arm broke and fell off. It did not hit the patient or the user or the table or the floor. The cables connected to the console and the powerhead caught before the injector fell to the ground. There was no patient harm. There were no iv bags or bottles hung. They have installed the powerhead on a remote roll stand and are continuing to use the injector.
Patient Sequence No: 1, Text Type: D, B5
[8173725]
Liebel - flarsheim manufacturer report: suspension arm received by lf 01/24/2007 for evaluation by lf product engineering. It was noted that the arm was broken at the weld on the second section of the articulating arm. This type of break is consistent with the type of break that generated the mcmahon suspension arm recall in 2002. The j-bow is within the range of parts included in the recall. Suspension replaced, injector returned to full service by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2008-00131 |
| MDR Report Key | 1279224 |
| Report Source | 01,05,06,07 |
| Date Received | 2009-01-07 |
| Date of Report | 2007-01-09 |
| Date of Event | 2007-01-04 |
| Date Mfgr Received | 2007-01-09 |
| Device Manufacturer Date | 2000-11-01 |
| Date Added to Maude | 2009-01-07 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH ROAD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARM + BRACKET ASSY |
| Generic Name | CT POWER INJECTOR SYSTEM |
| Product Code | IYB |
| Date Received | 2009-01-07 |
| Model Number | CT9000ADV |
| Catalog Number | 241047 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL - FLARSHEIM CO. |
| Manufacturer Address | 2111 E GALBRAITH RD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-07 |