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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: YOUNG INNOVATIONS PANORAMIC X-RAY MODEL PC 1000

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YOUNG INNOVATIONS PANORAMIC X-RAY MODEL PC 1000 Back to Search Results
Model Number 800724-3
Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)
Patient Problem No Patient Involvement (2645)
Event Date 03/26/2018
Event Type  malfunction  
Manufacturer Narrative
The panoramic certified technician from tlm was doing a pm and found the proper set screws for the tube head to be missing and incorrect set screws were in the tube head. The tube head did not fall again between service calls. The correct set screws were ordered and the technician went back to the office to install them and align the tube head. Pm done. Tube head is correctly secured and realigned. No leaks found in the tube head. Resolved. Closed ad. Quality determination: the fall of the tube head could have potentially caused or contributed serious injury. Therefore, the incident has been deemed an mdr reportable event to fda.
 
Event Description
Dr. (b)(6) told panoramic that they were re-aligning the tube head between pan and ceph and the tube head fell off the arm. It did not hit or injure any staff/patient members. The office technician mounted the tube head back onto the machine and now appear to have alignment issues.
 
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Brand NamePANORAMIC X-RAY MODEL PC 1000
Type of DevicePC 1000
Manufacturer (Section D)
YOUNG INNOVATIONS
4321 goshen rd.
fort wayne IN 46818
Manufacturer (Section G)
YOUNG INNOVATIONS
4321 goshen rd.
fort wayne IN 46818
Manufacturer Contact
adrienne demland
4321 goshen rd.
fort wayne, IN 46818
8006542027
MDR Report Key7426087
MDR Text Key105691053
Report Number1832462-2018-00002
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K882436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Dentist
Remedial Action Repair
Type of Report Initial
Report Date 04/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Model Number800724-3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/12/2018 Patient Sequence Number: 1
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