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 2011-12-22 for HUT EXT DR FINAL ASSY - REVERSE 404007 manufactured by Liebel-flarsheim Co..
[2569000]
On (b)(6): customer reports via phone that during an undetermined urology procedure, the system fluoro failed and staff had to move the patient to another room. Procedure was completed with portable c-arm fluoro unit in another room w/o further incident. Customer provided no patient or procedural information other than to say the procedure was completed and patient is fine. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
[9584064]
Pending investigation. Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2011-00249 |
| MDR Report Key | 2422629 |
| Report Source | 05,06,07 |
| Date Received | 2011-12-22 |
| Date of Report | 2011-12-22 |
| Date of Event | 2011-12-11 |
| Date Mfgr Received | 2011-12-11 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2012-07-25 |
| 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 |
| Generic Name | UROLOGY SUITE |
| Product Code | KQS |
| Date Received | 2011-12-22 |
| 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 | 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 | 2011-12-22 |