MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC X-RAY MODEL PC-1000/LASER1000; PC-1000/LASER 1000

Model Number 800724-3

Device Problems Mechanical Problem (1384); Device Operational Issue (2914); Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2017

Event Type  malfunction  

Manufacturer Narrative

Our service technician tried to follow up with customer on 5/12/2017 to see if they wanted to schedule a repair and was told that the dentist was out of the office.A motor replacement will be required to repair the machine.Motor has not been returned.

Event Description

The office technician, dennis, indicated the machine suddenly came down.He confirmed no one was in the machine at the time and no injuries had occurred.He was told the machine could possibly be repairable and that it needs the lift motor replaced.

• Brand Name: PANORAMIC X-RAY MODEL PC-1000/LASER1000
• Type of Device: PC-1000/LASER 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: adrienne demland ; 4321 goshen road; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 6570517
• MDR Text Key: 75332291
• Report Number: 1832462-2017-00008
• Device Sequence Number: 1
• Product Code: EHD
• UDI-Device Identifier: 00862309000316
• UDI-Public: 00862309000316
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Service Personnel
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Model Number: 800724-3
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2002
• 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