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

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.

• Brand Name: PANORAMIC X-RAY MODEL PC 1000
• Type of Device: PC 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 Key: 7426087
• MDR Text Key: 105691053
• Report Number: 1832462-2018-00002
• Device Sequence Number: 1
• Product Code: EHD
• UDI-Device Identifier: 00086209000316
• UDI-Public: 0086209000316
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882436
• Number of Events Reported: 1
• 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 Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 800724-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other