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U.S. Department of Health and Human Services

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

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LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY,ST,FPD Back to Search Results
Model Number 414008
Device Problems Use of Device Problem (1670); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/22/2018
Event Type  malfunction  
Event Description
Technologist reports that she was able to shoot xray yesterday. The technologist did not indicate that fluoro or xray was attempted prior to this case. The technologist indicated that the sedecal console screen was stuck on setting exposure parameters, please wait, which indicated the generator console does not have communication with the xray generator. Report recipient had technologist find the generator breaker, this was found in the off position, and had her turn off the generator console and then turn on the generator breaker. Turned on the generator console, this time the exposure parameters were set. Report recipient had technologist have the infirmed nexus rebooted. Then once logged in we opened the patient file. We then attempted to fluoro to no avail. The message center display indicated footpedal released exposure cancelled. We then exited the patient file and then reopened to verify the patient file is open. Attempted exposure again to no avail. After determining the system will not expose, the patient on the table under anesthesia was moved to another system to complete the case. The customer expressed her concern about the system and would like someone to come out as soon as possible to address this issue. No injuries were reported at this time.
 
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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 road
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e galbraith road
cincinnati, OH 45237
MDR Report Key7706103
MDR Text Key114852098
Report Number1518293-2018-00025
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2018
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 Received06/22/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/31/2017
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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