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 HUTIV FINAL ASSY,STD,LEFT 400002 manufactured by Liebel-flarsheim Co..
[2490025]
On (b)(6): customer reports via phone that staff were performing a retrograde pyelogram on a large male patient, approximately (b)(6), when the x-ray tube overheated due to physician consistent use of fluoro, system losing fluoro capability. Staff moved the patient to another room where the procedure was completed without further incident. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
[9637196]
Product monitoring follow up: customer reports after completion of procedure, they returned to the room and the system was functional. There is no further problem with the system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2012-00032 |
| MDR Report Key | 2462721 |
| Report Source | 05,06,07 |
| Date Received | 2012-02-14 |
| Date of Report | 2012-02-14 |
| Date of Event | 2012-02-04 |
| Date Mfgr Received | 2012-02-04 |
| Device Manufacturer Date | 1993-03-01 |
| 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 | HUTIV FINAL ASSY,STD,LEFT |
| Product Code | KQS |
| Date Received | 2012-02-14 |
| Model Number | HUTIV |
| Catalog Number | 400002 |
| 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 |