• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY,ST,FPD Back to Search Results
Model Number 414008
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
10/19/20: unable to duplicate the reported. Rebooted the entire system, (nexus, generator, gim), verified operation according to service checklist ((b)(4)). The system is fully functional.
 
Event Description
This incident was reported by a facility in (b)(6) on (b)(6) 2020. The customer states that the fluoro stopped during procedure. The tech had to restart the infimed several times in order to complete the procedure. The reporter also states that the patient was attached to the device during the incident but there was no harm to patient or staff, and that the procedure was completed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHUT EXT DR FINAL ASSY,ST,FPD
Type of DeviceHUT EXT DR FINAL ASSY,ST,FPD
Manufacturer (Section D)
LIEBEL-FLARSHEIM
2111 e. galbraith rd
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e. galbraith rd
cincinnati, OH 45237
MDR Report Key10828714
MDR Text Key247662307
Report Number1518293-2020-00033
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Inspection
Type of Report Initial
Report Date 10/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number414008
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 Received10/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-