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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; EXTRAORAL SOURCE X-RAY SYSTEM
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; EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Device Problems Device Operational Issue (2914); Radiation Underexposure (3018)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2016
Event Type  malfunction  
Event Description
Patient came to radiology for panorex x-ray.While examining patient, the panorex machine malfunctioned and did not fully expose the patient.Only the left side of the patient was exposed and the right side was blurred out completely.Biomed was made aware of the situation.They promptly came over and checked out the situation and believed that the situation was taken care of, and another attempt was made.During the second attempt the machine malfunctioned again and did not go fully around the patient nor did it go back around after the exposure was made.The patient was sent back to her room and radiology management was made aware.Biomed is currently fixing the equipment, and the ordering physician was made aware and is okay with waiting until the equipment is fixed to get the imaging done.
 
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Type of Device
EXTRAORAL SOURCE X-RAY SYSTEM
MDR Report Key6121075
MDR Text Key60679412
Report Number6121075
Device Sequence Number0
Product Code EHD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/22/2016
Event Location Hospital
Date Report to Manufacturer09/22/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Age44 YR
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