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

Model Number 424007

Device Problem Disconnection (1171)

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

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: guerbet's technical support received a call from customer's biomed who reported that the generator disconnected' symbol came up on the left side of the screen during a patient case.After power cycling the generator, the communication could not be reestablished.A portable c-arm was brought in to complete the case without moving the patient.The case was completed before the biomed contacted guerbet's technical support.Guerbet's technical support assist the biomed in troubleshooting, identifying a possible system communication issue with the ifc1 pcb in the generator.Guerbet sent their field service engineer (fse) on site to investigate the issue.The fse confirmed and resolved the problem by replacing the generator ifc1 pcb, part number 460387- 001-usg.After replacement of the pcb, the fse verified that the system was performing to specifications via hvdis table service checklist qssrwi4.5.Since the system proved to be fully functional, it was returned to customer use.A review of cts shows no similar issues reported on this unit.Root / probable cause code: equipment/instrument - failure.Root / probable cause 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.Disposition summary: unit returned to full service.

Event Description

Initial information was received on (b)(6) 2020, as reporter states that the "generator disconnected" came up on the left side of the screen during a patient case, and after power cycling the generator, the connection could not be reestablished.

• Brand Name: HVDIS TABLE, REVERSE WITH FPD
• Type of Device: HVDIS TABLE, REVERSE WITH FPD
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e galbraith road; cincinnati, oh
• Manufacturer Contact: fred reckelhoff ; 2111 e galbraith road; cincinnati, oh
• MDR Report Key: 9793927
• MDR Text Key: 200625170
• Report Number: 1518293-2020-00003
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/03/2020

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: 02/03/2020
• Initial Date FDA Received: 03/05/2020
• 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