MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC X-RAY PC- MODEL1000; PC-1000, PRODUCT CODE: EHD

Model Number PC-1000

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2016

Event Type  malfunction  

Event Description

The dentist and office manager ((b)(6)) called to report the x-ray machine came down after patient exited the machine.The machine will not raise anymore.

• Brand Name: PANORAMIC X-RAY PC- MODEL1000
• Type of Device: PC-1000, PRODUCT CODE: EHD
• 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: stephen yaggy ; 4321 goshen road; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 5632419
• MDR Text Key: 45205881
• Report Number: 1832462-2016-00003
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 12449
• 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: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Hygienist
• Device Model Number: PC-1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2002
• 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