MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-12-16 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim Co..
[2568719]
On (b)(6): customer reports that an unidentified pt was having a urology procedure with stent placement. During the stent placement, the system fluoro failed. Physician used the endoscope to visualize placement of the stent. Procedure was completed w/o further incident. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
[9581554]
Field service engineer (fse) discussed issue with customer who said intermittently, the infimed system has a pop up that says (ready to update). If they catch it they can decline it and the system functions normally. If not, the system goes to desk top screen and they have to reboot to complete the case. Troubleshot system and found the customer was using symantec endpoint virus protection with 'auto update' selected. This was causing the system to 'auto update' during their cases. Fse contacted hospitals it person and explained what was happening and that the system needed the virus protection ran manually. There was no problem with the covidien equipment. Fse completed the minor imaging portion of the hydravision dr system service checklist and returned system to full service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2011-00244 |
| MDR Report Key | 2412197 |
| Report Source | 06,07 |
| Date Received | 2011-12-16 |
| Date of Report | 2011-12-05 |
| Date of Event | 2011-12-05 |
| Date Mfgr Received | 2011-12-05 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2012-04-17 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 E. 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 | HUT EXT DR FINAL ASSY-REVERSE |
| Generic Name | UROLOGY SUITE |
| Product Code | KQS |
| Date Received | 2011-12-16 |
| Model Number | HUT EXT DR |
| Catalog Number | 404007 |
| 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 | 2011-12-16 |