MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-09-04 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim Company.
[3803074]
Customer states via phone at the beginning of the procedure, the physician stepped on the reverse trendelenburg footswitch, after he released the pedal, the table continued placing the table in an upright position. The table reached its stop point and the pt was able to get back on the stretcher. At that time, biomed was able to remove the footpedal. The system was fully functional with the handswitch and the physician was able to complete the cause in that manner. No pt or procedural info is available. No pt injury.
Patient Sequence No: 1, Text Type: D, B5
[11225515]
Customer called and ordered a replacement fluoro footswitch. Product monitoring f/u with the customer who said that during the case biomed was able to come down and remove the footpedal and the system was fully functional with the handswitch. The physician was able to complete the case in that manner. The new footswitch had been installed the next day and the system was fully functional.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2013-00206 |
| MDR Report Key | 3380687 |
| Report Source | 06,07 |
| Date Received | 2013-09-04 |
| Date of Report | 2013-08-08 |
| Date of Event | 2013-08-08 |
| Date Mfgr Received | 2013-08-08 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2013-12-03 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | HUT EXT DR |
| Product Code | KQS |
| Date Received | 2013-09-04 |
| Model Number | 404007 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM COMPANY |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-04 |