MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC X-RAY MODEL PC-4000

Model Number 801125-5

Device Problems Maintenance Does Not Comply To Manufacturers Recommendations (2974); Device Handling Problem (3265)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Event Description

A phone call was received from a (b)(6) service technician.He wanted to send us pictures of a pc-4000 that fell forward while it was being relocated it to a storage facility.No injuries reported.No pictures have been received.The tech was contacted again.No response.

• Brand Name: PANORAMIC X-RAY MODEL PC-4000
• Type of Device: PC-4000
• 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: 5808423
• MDR Text Key: 49974493
• Report Number: 1832462-2016-00006
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• PMA/PMN Number: K043557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Service and Testing Personnel
• Device Model Number: 801125-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other