MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC X-RAY MODEL PC-1000

Model Number 800724-1

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 05/10/2016

Event Type  malfunction  

Event Description

A recall for this issue was initiated on 23-apr-2015.Office called, stated the machine unexpectedly dropped and the dr tried to stop it.

• Brand Name: PANORAMIC X-RAY MODEL PC-1000
• Type of Device: PC-1000
• 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: 5708985
• MDR Text Key: 46892412
• Report Number: 1832462-2016-00004
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• PMA/PMN Number: K870236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 800724-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2001
• 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