MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE

Model Number 404007

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• Type of Device: HUT EXT DR FINAL ASSY-REVERSE
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e galbraith road; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e galbraith road; cincinnati, OH 45237
• MDR Report Key: 8320734
• Report Number: 1518293-2019-00002
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 404007
• Was Device Available for Evaluation?: No Answer Provided

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage