MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY,RE,FPD

Model Number 414007

Device Problem Image Display Error/Artifact (1304)

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

Event Date 08/17/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018 report receiver spoke with (b)(6), the technician at the facility.She reported that a patient was on the table at the time of the call.The ddis tube shroud display is indicating preparing to expose, but no exposure is occurring.She states that she got out of the application on the nexus and got back in to no avail.She was not able to locate the gim box to try a power cycle on it.The patient case was over at this point and she needed to end the call.She said she would send the call to ge because they handle the account.Report receiver spoke with (b)(6) again on 30 august 2018.(b)(6) states that after the original call, the system was down and reboots of the system did not help.She said that the infirmed computer tower was real loud.Their service provider, ge, came in and repaired the system.She does not know what they replaced or did, but the system is currently working without issue.

• Brand Name: HUT EXT DR FINAL ASSY,RE,FPD
• Type of Device: HUT EXT DR FINAL ASSY,RE,FPD
• 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: 7876423
• MDR Text Key: 120540617
• Report Number: 1518293-2018-00031
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 414007
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2018
• Date Device Manufactured: 01/31/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1