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

Model Number	800724-1
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Unintended Movement (3026)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2016 a service call was received from (b)(6) secretary.She reported that the machine had fallen on (b)(6) 2016 and will not rise anymore.No patient was involvement and no injuries occurred.

• Brand Name: PANORAMIC X-RAY MODEL PC-1000/LASER-1000
• Common Device Name: PC-1000/PC-1000 FILM
• Manufacturer (Section D): PANORAMIC CORPORATION; 4321 goshen road; fort wayne IN 46818
• MDR Report Key: 6230297
• Report Number: 1832462-2017-00001
• Device Sequence Number: 938441
• Product Code: EHD
• UDI-Device Identifier: 00862309000316
• UDI-Public: 00862309000316
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K882436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2017

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 Assistant
• Device Model Number: 800724-1
• 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: 01/06/2017
• 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