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 2012-02-14 for HUT EXT DR FINAL ASSY-STANDARD 404008 manufactured by Liebel-flarsheim Co..
[2522803]
On (b)(6): customer reports via phone that during an undetermined urology procedure on a male patient, the system lost fluoro capability. Staff brought a portable c-arm fluoro unit into the room and physician completed the procedure without 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
[9714490]
Product monitoring follow up: the customer reported they had replaced the computer hard drive and system is now able to fluoro. System is operating normally.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2012-00031 |
| MDR Report Key | 2462720 |
| Report Source | 05,06,07 |
| Date Received | 2012-02-14 |
| Date of Report | 2012-02-14 |
| Date of Event | 2012-02-03 |
| Date Mfgr Received | 2012-02-03 |
| Device Manufacturer Date | 2007-04-01 |
| Date Added to Maude | 2012-08-16 |
| 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-STANDARD |
| Product Code | KQS |
| Date Received | 2012-02-14 |
| Model Number | HUT EXT DR |
| Catalog Number | 404008 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2012-02-14 |