MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-11-29 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim Co..
[2330930]
On (b)(6): customer says the table indicates preparing to expose when either the fluoro or digital rad footswitch is pressed, but will not expose. Pt was on the table and they could not troubleshoot over the phone. Customer said they have an alternate room they are moving the pt into. On (b)(6): customer reports the pt procedure was completed without further incident. No reported injury. Customer did not provide the pt and procedural info, other than to say the procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
[9600177]
Field service engineer (fse) called customer regarding the report that the unit would not expose. Fse had the customer reboot the system and the customer said that everything works fine now. The customer no longer wanted a fse visit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2011-00237 |
| MDR Report Key | 2397226 |
| Report Source | 05,06,07 |
| Date Received | 2011-11-29 |
| Date of Report | 2011-11-19 |
| Date of Event | 2011-11-19 |
| Date Mfgr Received | 2011-11-19 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2012-07-18 |
| 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 | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH RD. |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUT EXT DR FINAL ASSY-REVERSE |
| Generic Name | UROLOGY SUITE |
| Product Code | KQS |
| Date Received | 2011-11-29 |
| Model Number | HUT EXT DR |
| Catalog Number | 404007 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM CO. |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-29 |