MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-08 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim.
[135864369]
Overall investigation summary: a hospital notified guerbet service that during a case, smoke emitted from the hydra vision's table tower, just prior to the left monitor going blank. Although there was no harm to the patient or caregiver, the case was halted due to the smoke. Since the smoke triggered a smoke alarm, the local fire department responded; however, no flames were detected. The hospital biomed examined the table and found the left monitor's power supply was defective and smelled of smoke. Guerbet's field service engineer visited the account and replaced the power supply of this 14-year old system. After verifying proper operation according to hydra vision dr system service checklist qssrwi4. 1, the field service engineer returned the system to full service. A review of guerbet's complaint tracking system indicated no similar such issues with this machine. Root/probable cause code: equipment/instrument - failure. Root/probable cause summary: it is believed that age may have been a factor, since the defect occurred past the expected life of the device. Power supplies like other electronic equipment has a greater chance of failing with age and continuous use. The power supply was designed to conform to both ul 60601-1 and iec 60601-1 electrical safety standards, and therefore equipped with flame retardant covers. Guerbet will continue to monitor and trend such events during metric and management reviews for additional investigation and or corrective action consideration. Disposition summary: unit returned to full service.
Patient Sequence No: 1, Text Type: N, H10
[135864370]
This incident was reported on (b)(6) 2019 as a reporter states that there was possible smoking from monitor, but states that for sure started while patient was on the table. The reporter states that the event occurred during a procedure, and that there was no injury to patient or staff. Reporter states that it may possibly be the monitor power supply, and the resulting smoke set off the fire alarm and the fire department was called to the hospital. Reporter states that he will supply images of the burnt power supply.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2019-00002 |
| MDR Report Key | 8320734 |
| Date Received | 2019-02-08 |
| Date of Report | 2019-01-10 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2018-12-17 |
| Device Manufacturer Date | 2012-08-31 |
| Date Added to Maude | 2019-02-08 |
| 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 | 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HUT EXT DR FINAL ASSY-REVERSE |
| Generic Name | HUT EXT DR FINAL ASSY-REVERSE |
| Product Code | IXR |
| Date Received | 2019-02-08 |
| Model Number | 404007 |
| 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 | 2019-02-08 |