MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC X-RAY PC-1000/LASER1000; PC1000 / LASER 1000

Model Number 800724-3

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2016

Event Type  Injury  

Manufacturer Narrative

There was no serious injury; there was a potential for serious injury.

Event Description

The machine began to drift down with a child patient in the machine.It was reported that the patient was tapped on the head, that no injury occurred and no treatment sought.Retrospective review for complaints on drift.

• Brand Name: PANORAMIC X-RAY PC-1000/LASER1000
• Type of Device: PC1000 / 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: tammy shiffler ; 4321 goshen road; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 5967354
• MDR Text Key: 55313989
• Report Number: 1832462-2016-00013
• 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: Health Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Assistant
• Device Model Number: 800724-3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2006
• 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): Other