MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-01-07 for BUCKY/ACL-110 VOLT SIZE WALL BUCKY 249112SL manufactured by Liebel - Flarsheim Co..
[980865]
Customer reports that during automatic ejection, the 10 x 12 cassette does not stay in place, but "falls to the floor. "
Patient Sequence No: 1, Text Type: D, B5
[8171300]
Liebel flarsheim manufacturing report: liebel flarsheim was not able to reproduce the problem with the two types of 10" x 12" cassettes that we have in-house. In discussions with the technical services and the product engineer, we could only surmise that the cassete's forward motion was continuing after the cassette release, propelling it to the floor. However, the 'rails' in which the cassette rides would still be engaged and not allow the cassette to tip-out even if the cassette was half way out of the opening. The only way that the rails would not hold the cassette would be if the entry sensor fails, causing the rails to return to their home position. It was also suggested that by taping the cassette edges, you can increase rail friction, or to suggest discontinue the use of the automatic eject mode as means to eliminate the problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2008-00044 |
| MDR Report Key | 1278961 |
| Report Source | 06 |
| Date Received | 2009-01-07 |
| Date of Report | 2003-04-07 |
| Date Mfgr Received | 2003-04-07 |
| Device Manufacturer Date | 2001-05-01 |
| Date Added to Maude | 2009-04-20 |
| 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 RD |
| 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 | BUCKY/ACL-110 VOLT SIZE |
| Generic Name | CASSETTE WALL BUCKY SYSTEM |
| Product Code | IXA |
| Date Received | 2009-01-07 |
| Model Number | WALL BUCKY |
| Catalog Number | 249112SL |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 |