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U.S. Department of Health and Human Services

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

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LIEBEL-FLARSHEIM HVDIS TABLE, REVERSE WITH FPD Back to Search Results
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.
 
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Brand NameHVDIS TABLE, REVERSE WITH FPD
Type of DeviceHVDIS 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 Key9793927
MDR Text Key200625170
Report Number1518293-2020-00003
Device Sequence Number1
Product Code IXR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received03/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number424007
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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