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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE

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LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE Back to Search Results
Model Number 404007
Device Problems Erratic or Intermittent Display (1182); Self-Activation or Keying (1557); Communication or Transmission Problem (2896); Optical Problem (3001); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2020
Event Type  malfunction  
Event Description
This incident was reported by a facility in (b)(6) on (b)(6) 2020. Incident: the reporter states that while flouring with footswitch, both monitors are glitching and the infirmed is continuously taking images even after releasing footswitch, but the images are all blank. The reporter also states that since the images are blank, it is not actually taking images, and when they try to view an image, it stays for about 10 seconds and then is replaced with a blank image continuously. He stated that he has rebooted the generator at this point to no avail. When he attempted to exit the application, the system would not respond, and had to make multiple attempts to exit. Reporter also stated later that he was getting a camera communication failure on the infirmed. Reporter states that the incident occurred during a procedure and that there was a patient attached to the device during the incident, but there was no injuries to patient or staff.
 
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Brand NameHUT EXT DR FINAL ASSY-REVERSE
Type of DeviceHUT EXT DR FINAL ASSY-REVERSE
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 Key10787228
MDR Text Key225122705
Report Number1518293-2020-00030
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 Other Health Care Professional
Type of Report Initial
Report Date 10/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number404007
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 Received10/07/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/30/2008
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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