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

Model Number	800724-3
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ceph head was not clamped down correctly and a string was attached to secure the ceph head.The doctor said the reason it was not clamped down was he could not get the screws back in correctly.Panoramic sent a technician out to insure the ceph head was secured and the machine is working properly.The machine was operating properly and the ceph head was reclamped down.Picture attached.(b)(4).
Event or Problem Description
Dr (b)(6) mentioned the ceph head fell off the machine and near his foot.There was no injury and no medical treatment was necessary.This incident occurred about a month and half ago.

• Brand Name: PANORAMIC X-RAY MODEL PC-1000
• Common Device Name: PC-1000 / LASER 1000
• Manufacturer (Section D): YOUNG INNOVATIONS; 4321 goshen road; fort wayne IN 46818
• MDR Report Key: 7823373
• Report Number: 1832462-2018-00005
• Device Sequence Number: 16466407
• Product Code: EHD
• UDI-Device Identifier: 00862309000316
• UDI-Public: 00862309000316
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K882436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/27/2018

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: Health Professional
• Device Model Number: 800724-3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/28/2018
• 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