MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-18 for HUT EXT DR FINAL ASSY-STANDARD 404008 manufactured by Liebel-flarsheim.
[139431681]
Overall investigation summary: guerbet's tech support received a call from a hospital technician who reported that, during a procedure, they raised the table of their hydra vision urology system. After reaching its 'up' most position, the table got stuck and would not respond to the hand or foot switch. The procedure was completed as planned with no risk or injury to the patient or care giver. To assist the technician in identifying possible causes of the stuck table, tech support instructed the technician to pull down on the splash cover to insure that the limit switch was not obstructed. Additionally, tech services advised the technician to power-cycle the table, which the technician did after the procedure. By power-cycling the table, the technician was able to lower the table normally, and remove the patient. In a later tech service follow-up call, the operating room director stated that by power-cycling the system, it became fully functional, and as remained in this condition since, and that there was no need to have a field service engineer visit to examine the system. System remained in full service. Root/probable cause code: equipment/instrument - failure. Root/probable cause summary: refer to investigation summary. Since a power-cycle returned the system to fully operational, the root cause is unknown, and no further investigation is required at this time. A review of guerbet's complaint tracking system showed no similar issues with this device. No capa required at this time, qa will continue to monitor and trend such issues during quality metrics and management reviews for additional corrective action consideration. Disposition summary: unit remained in full service.
Patient Sequence No: 1, Text Type: N, H10
[139431682]
This incident was reported on (b)(6) 2019 as reporter states that there was patient on the table, and that the team put the table all the way up, and at the time of the call, the table would not go back down. The reporter states that there was a patient on the table at the time of the call, and that they had the table all the way up elevation and the table will not lower with the hand or foot switch. Call receiver states that he had the reporter try and grab the splash crash cover and pull down on it in case a splash crash micro switch was stuck, which would cause this symptom. Reporter stated that she was not successful, and that they would finish the case and will try and remove the patient from the table elevated. Reporter states that there was no injury to patient or staff. On follow-up call with the facility, the operating room director stated that the issue was resolved the same day that it occured. The director states that they did not want to cycle power on the table during the procedure, so they finished the patient case first. The director states that when the patient case was complete they cycled power on the table and the table would then lower so that they could easily take the patient off the table. The table has had no issue since and they do not request service to come to the site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2019-00005 |
| MDR Report Key | 8429015 |
| Date Received | 2019-03-18 |
| Date of Report | 2019-02-19 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-02-19 |
| Device Manufacturer Date | 2008-07-31 |
| Date Added to Maude | 2019-03-18 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRED RECKELHOFF |
| Manufacturer Street | 2111 E GALBRAITH ROAD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HUT EXT DR FINAL ASSY-STANDARD |
| Generic Name | HUT EXT DR FINAL ASSY-STANDARD |
| Product Code | IXR |
| Date Received | 2019-03-18 |
| Model Number | 404008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 E GALBRAITH ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-18 |