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 2012-02-28 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim Co.
[2474555]
(b)(6): customer reports when staff attempted to start the urology system for days procedures, the monitors failed to work. Patient procedures were canceled. Customer does not have a back up room. No reported injuries. Customer reports all procedures have been delayed pending room repair.
Patient Sequence No: 1, Text Type: D, B5
[9610293]
Field service engineer (fse) troubleshot the no fluoro image problem and found both monitors on tower worked in last image hold (lih) channel 11. Fse then swapped video input at the monitors and image swapped, then fse went to bnc on platinum one computer and flexed it and the monitor came up in channel 10. Fse determined from this that the unit needs a bnc cable ph 704051 or video pcb pn 710293. The unit is currently working. When fse asked for approval from customer for parts replacement, customer wanted to open another service request with different po# to cover video pcb 710293, and bnc cable 704051 and labor at a later date. Fse completed hydravision service checklist with reference service manual, and found all readings within tolerance. Unit passed checkout procedures and was returned to full service by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2012-00041 |
| MDR Report Key | 2480328 |
| Report Source | 05,06,07 |
| Date Received | 2012-02-28 |
| Date of Report | 2012-02-28 |
| Date of Event | 2012-02-16 |
| Date Mfgr Received | 2012-02-16 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2012-08-24 |
| 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 | HUT EXT DR FINAL ASSY-REVERSE |
| Product Code | KQS |
| Date Received | 2012-02-28 |
| Model Number | HUT EXT DR |
| Catalog Number | 404007 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2012-02-28 |