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

Model Number 800724-3

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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
• Type of Device: PC-1000 / LASER 1000
• Manufacturer (Section D): YOUNG INNOVATIONS; 4321 goshen road; fort wayne IN 46818
• Manufacturer (Section G): YOUNG INNOVATIONS; 4321 goshen road; fort wayne IN 46818
• Manufacturer Contact: tammy shiffler ; 4321 goshen road; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 7823373
• MDR Text Key: 118553405
• Report Number: 1832462-2018-00005
• Device Sequence Number: 1
• Product Code: EHD
• UDI-Device Identifier: 00862309000316
• UDI-Public: 00862309000316
• 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
• Reporter Occupation: Dentist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 800724-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2000
• 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