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.
[2394614]
(b)(6): customer reports via phone that staff were attempting to do an undetermined urology procedure when the system failed and they could not fluoro. Staff moved the patient to another room where the physician completed the procedure without further incident. Customer did not provide patient or procedural information other than to say the patient is fine, procedure was completed. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
[9608227]
Tech support (ts) contacted infimed support for assistance with biomed. Infimed determined that the file was corrupted, and assisted in getting the patient database error cleared and reconnection made to the patient database. Biomed opened a test patient and verified the fluoro / digital spots and the system is fully functional. Returned to full service by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2012-00038 |
| MDR Report Key | 2480334 |
| 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 | 2008-01-01 |
| Date Added to Maude | 2012-08-23 |
| 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 | N |
| Device Age | DA |
| 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 | 2012-02-28 |