MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC X-RAY PC-1000; PC-1000/LASER 1000

Medical Device Problem Codes	Migration or Expulsion of Device (1395); Unintended Movement (3026)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
A recall for this issue was initiated on 23-apr-2015.The office's technician (b)(4) called us and let us know the machine came down suddenly.During the investigation it was discovered that the machine was being lowered for the x-ray when the machine came down unexpectedly.No patients or staff members were injured.

• Brand Name: PANORAMIC X-RAY PC-1000
• Common Device Name: PC-1000/LASER 1000
• Manufacturer (Section D): PANORAMIC CORPORATION; 4321 goshen road; fort wayne IN 46818
• MDR Report Key: 6277771
• Report Number: 1832462-2017-00004
• Device Sequence Number: 1056740
• Product Code: EHD
• UDI-Device Identifier: 00862309000316
• UDI-Public: 00862309000316
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K882436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 01/25/2017

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: Dental Hygienist
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1