MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-01-31 for HUT EXT DR FINAL ASSY - STANDARD 404008 manufactured by Liebel-flarsheim Co.
[21988462]
On (b)(6), customer reports via phone during a unk pt urology procedure, when they tried to move the x-ray tube or monitors, the system would shut completely down. Customer reports system was unable to be rebooted. Physician completed procedure. No pt injuries were reported. Pt gender and age were not known. Facility does have back-up capabilities.
Patient Sequence No: 1, Text Type: D, B5
[22199763]
Field service engineer (fse) troubleshot to a failing 24v power supply that would not regulate and replaced the power supply. Fse also found the monitor collision error was due to failed tape switch. The switch should be open or closed and this tape switch would not fully open. Fse ordered a new monitor collision tape switch which the customer wants to install. On (b)(6), fse contacted customer who reported the tape switch was installed and the system is working properly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2012-00020 |
| MDR Report Key | 2447141 |
| Report Source | 06,07 |
| Date Received | 2012-01-31 |
| Date of Report | 2012-01-31 |
| Date of Event | 2012-01-18 |
| Date Mfgr Received | 2012-01-18 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2012-08-10 |
| 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 | 0 |
| 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 | 5139485714 |
| 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 | 2012-01-31 |
| Model Number | HUT EXT DR |
| Catalog Number | 404008 |
| 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 | 2012-01-31 |