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 HUTIV TABLE ASSY REV W/COLOR 400005 manufactured by Liebel-flarsheim Co..
[2331426]
On (b)(6) 2011: customer reports via phone that during a cystoscopy procedure, the fluoro failed. Procedure was completed by using a portable fluoro c-arm. No pt injury to report.
Patient Sequence No: 1, Text Type: D, B5
[9600708]
Field service engineer (fse) turned on the system and found it was working correctly, could not reproduce the 'no fluoro' problem. Fse found that when a tube warm up was done, the generator does the shot and then gives the message 'tube calibration required', however, the customer does not want to put anymore time into this unit at this time and does not want to incur the cost to have the tube calibrated. Fse verified operation using the hut iv info in the legends training manual and returned the unit to customer for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2011-00232 |
| MDR Report Key | 2397204 |
| Report Source | 05,06,07 |
| Date Received | 2011-11-29 |
| Date of Report | 2011-11-11 |
| Date of Event | 2011-11-11 |
| Date Mfgr Received | 2011-11-11 |
| Device Manufacturer Date | 1994-10-01 |
| 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 |
| Manufacturer Phone | 5139485719 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUTIV TABLE ASSY REV W/COLOR |
| Generic Name | UROLOGY SUITE |
| Product Code | KQS |
| Date Received | 2011-11-29 |
| Model Number | HUTIV |
| Catalog Number | 400005 |
| 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 EAST GALBRAITH RD. CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-29 |