MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HVDIS TABLE, REVERSE WITH FPD

Model Number 424007

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: fse had initially gone on site (d11673) to investigate an error 0017 on the generator, troubleshot and found no cathode continuity in the x-ray tube.Fse replaced the x ray tube then had the pc tower crash.Fse replaced the hard drive but the issue remained.The pc was returned to varex for warranty repair.Varex reported that after the hard drive replacement the boot order had changed.Varex corrected the boot order and the computer functioned normally.Fse returned to site after computer was returned from varex, installed the pc and completed the spellman/nexus update (d11621).Verified operation according to service checklist qssrwi 4.5.The system was fully functional and returned to service.A review of cts shows no similar issues reported on this unit.Root.Impact assessment summary: na.Root / probable cause code: equipment/instrument - failure.Root / probable cause summary.Refer to investigation summary.No further investigation needed at this time.Qa will continue to monitor and trend for similar issues.No capa at this time, these trends and issues are reported on during quality metrics review and during the management review meetings to consider input for corrective action.Complaint confirmed: yes.Disposition summary: unit returned to service.

Event Description

Incident reported by facility on 10 june 2020 for an event that occurred on (b)(6) 2020.Facility stated power cycle generator was able to get two exposures and then could not get any more.It requires further diagnosis onsite by a fse.Facility stated error message appeared, error 17.The event occurred with no patient involvement.

• Brand Name: HVDIS TABLE, REVERSE WITH FPD
• Type of Device: HVDIS TABLE, REVERSE WITH FPD
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati, oh
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd; oh
• MDR Report Key: 10460307
• MDR Text Key: 219566478
• Report Number: 1518293-2020-00025
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 424007
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1