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

Model Number 800724-3

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Not Applicable (3189)

Event Date 08/25/2016

Event Type  malfunction  

Event Description

The original service call was from the doctor calling to obtain service for the machine he moved into the office recently.When he tried to take an x-ray a fuse blew.The field service tech replaced the fuse and calibrated the machine.When he tried to lower the machine it would not go down the last 8 to 10 inches.The doctor stated the when he moved the machine the top half was separated from the bottom half, separating the columns.The field service tech attached the ceph arm which had been removed during the move and was about to train the staff on how to use the machine when the upper half suddenly fell stopping 8 to 10 inches from the base.The doctor confirmed that the motor was not removed and reseated.A new motor was sent and the field service tech replaced it.

• Brand Name: PANORAMIC X-RAY MODEL PC-1000/LASER1000
• 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: 5967322
• MDR Text Key: 55286350
• Report Number: 1832462-2016-00012
• Device Sequence Number: 1
• Product Code: EHD
• 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: health professional,user faci
• Reporter Occupation: Service and Testing Personnel
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 800724-3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2003
• 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