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U.S. Department of Health and Human Services

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

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LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY-STANDARD Back to Search Results
Model Number 404008
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/05/2018
Event Type  malfunction  
Event Description
Initial complaint received on (b)(6) 2018. Reporter notified guerbet regarding an incident as described as monitor 1 no sync and no lights on viewmant hand control. Report receiver spoke with the biomed, who stated that this is an older 2004 hut dr with an lf 04 or lf 05 video distribution box. The video distribution box is only getting about 3v dc and so is not operating. Report receiver instructed reporter to find the 7. 5v dc video distribution power supply on the right side of the table. Reporter found it and determined it to be faulty. He wants to do the repair by himself and does not want an fse to come to the site. This event occurred during a procedure, this procedure was not completed, and was rescheduled. There was no reported injuries ot patient or staff. The procedure in this case was rescheduled, and as such, having to repeat a procedure where a patient needs to go under general anesthesia, potential re-exposure to x-ray, and the lack of maintenance information since it will be done locally, this case is considered for mdr reporting.
 
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Brand NameHUT EXT DR FINAL ASSY-STANDARD
Type of DeviceHUT EXT DR FINAL ASSY-STANDARD
Manufacturer (Section D)
LIEBEL-FLARSHEIM
2111 e galbraith road
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e galbraith road
cincinnati, OH 45237
MDR Report Key7931992
MDR Text Key123511809
Report Number1518293-2018-00036
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 user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number404008
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 Received09/05/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/31/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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