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

Model Number 800724-1

Device Problems Mechanical Problem (1384); Device Operational Issue (2914); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Information (3190)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

During the repair on (b)(6) 2016, our field service technician noted that it appeared maintenance on the machine was performed improperly.The motor was returned and our engineer performed an investigation on the motor.

Event Description

In support of the 2016 correction a field service technician was sent in to inspect the safety mechanism of two machines.He was unable to inspect one machine because the shaft would not spin and the machine would not travel up/down.Since this problem was not reported when the inspection was setup the technician did not have parts to repair the machine and would have to return to repair the machine.The repair was schedule and performed on (b)(6) 2016.During the repair it was determined that the screw motor had failed and the unit was supported by the safety nut.

• 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: tammy shiffler ; 4321 goshen road; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 6114113
• MDR Text Key: 60429077
• Report Number: 1832462-2016-00018
• Device Sequence Number: 1
• Product Code: EHD
• UDI-Device Identifier: 00862309000309
• UDI-Public: 00862309000309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K870236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• 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?: No
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2008
• 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