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

Model Number	800724-1
Medical Device Problem Codes	Mechanical Problem (1384); Device Operational Issue (2914); Unintended Movement (3026)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dentist emailed and stated that the screw motor assembly failed.The overhead chassis lightly made contact with a girl.The dentist applied antibiotic and a band-aid.The mother took the girl to the physician to make sure she was alright.The physician reapplied antibiotic and a band-aid.The girl was not hospitalized.The dentist purchased a screw motor and had it shipped to his office.He is having his own technician replace the motor since there are no panoramic certified technicians in (b)(4).
Event or Problem Description
Dr.(b)(6) notified us be email on (b)(6) 2018 that three weeks prior (1st week of (b)(6)approximately), a patient was entering the unit and the screw motor assembly failed.The overhead chassis made contact with the patient.On (b)(6) 2018, the doctor gave us the serial number and other required information for this incident so we could investigate and create a case.The screw motor is stuck now and will not go up.The patient was scraped on the cheek and shoulder.The patient was treated with antibiotic and a band-aid on the cheek.

• Brand Name: PANORAMIC X-RAY MODEL PC-1000
• Common Device Name: PC-1000
• Manufacturer (Section D): YOUNG INNOVATIONS; 4321 goshen rd.; fort wayne IN 46818
• MDR Report Key: 7598026
• Report Number: 1832462-2018-00003
• Device Sequence Number: 11078117
• Product Code: EHD
• UDI-Device Identifier: 00862309000309
• UDI-Public: 00862309000309
• Combination Product (Y/N): N
• PMA/510(K) Number: K870236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Repair,Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Dentist
• Device Model Number: 800724-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other