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 Missing Value Reason (3192)

Event Date 09/29/2016

Event Type  Injury  

Event Description

A recall for this issue was initiated on (b)(6) 2015.A call came in from an office stating that the machine had dropped down yesterday.No persons were involved.The machine had been making screeching noises in the days leading up to the drop as well as getting stuck while going up/down.It was stated by the dental assistant that they would just push on the machine and then the machine would continue to move.A conversation with the dr occurred on (b)(6) 2016.This is when we were informed that one for his staff had been injured when the machine fell.Additional information was requested but not delivered.

• 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: 6063994
• MDR Text Key: 58656677
• Report Number: 1832462-2016-00017
• 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: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• 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?: Yes
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/1999
• 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): Hospitalization