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 2011-12-06 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim Co..
[2502733]
On (b)(6): customer reports urology table movement hand and foot control not working. On (b)(6): customer reports via e-mail; pt gender and age (b)(6) female. Pt had to be transported from cysto room to another room to complete procedure. Pt was having esophageal retrograde cholangio pancreatography (ercp) by dr. (b)(6). We were able to perform the procedure successfully after changing rooms. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
[9578695]
Field service engineer (fse) troubleshot customer complaint of no table movement and found the hydradjust dr table hand control to be bad causing loss of table movement. Fse replaced the handswitch per hut service manual and checked for proper operation by completing hydradjust dr service checklist. Unit passed checkout procedures and ws returned to full service by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2011-00239 |
| MDR Report Key | 2373669 |
| Report Source | 05,06,07 |
| Date Received | 2011-12-06 |
| Date of Report | 2011-12-07 |
| Date of Event | 2011-11-18 |
| Date Mfgr Received | 2011-11-18 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2012-04-06 |
| 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 E. GALBRAITH ROAD |
| 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 | UROLOGY SUITE |
| Product Code | KQS |
| Date Received | 2011-12-06 |
| Model Number | HUT EXT DR |
| Catalog Number | 404007 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM CO. |
| Manufacturer Address | 2111 E. GALBRAITH RD. CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-06 |