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

Model Number 800724-1

Device Problems Mechanical Problem (1384); Device Operational Issue (2914); Unintended Movement (3026)

Patient Problem Abrasion (1689)

Event Date 05/02/2018

Event Type  malfunction  

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 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
• 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: 7598026
• MDR Text Key: 111058098
• Report Number: 1832462-2018-00003
• Device Sequence Number: 1
• Product Code: EHD
• UDI-Device Identifier: 00862309000309
• UDI-Public: 00862309000309
• Combination Product (y/n): N
• PMA/PMN Number: K870236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 800724-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/1998
• 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