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

Model Number 800724-1

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2016

Event Type  malfunction  

Event 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
• Type of Device: PC-1000/PC-1000 FILM
• Manufacturer (Section D): PANORAMIC CORPORATION; 4321 goshen road; fort wayne IN 46818
• Manufacturer (Section G): PANORAMIC CORPORATION; 4321 goshen road; fort wayne IN 46818
• Manufacturer Contact: tammy shiffler ; 4321 goshen road; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 6230297
• MDR Text Key: 64132982
• Report Number: 1832462-2017-00001
• Device Sequence Number: 1
• Product Code: EHD
• UDI-Device Identifier: 00862309000316
• UDI-Public: 00862309000316
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K882436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Assistant
• Device Model Number: 800724-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2001
• 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