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

Model Number 800724-1

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Missing Value Reason (3192)

Event Type  malfunction  

Manufacturer Narrative

Inspection of the machine and screwmotor was done on 6/2/2016.For an initial inspection of the machine, the shipping shrink wrap was removed and the machine was plugged in.As soon as the machine was plugged in the machine started rotating - the power button was left on.This machine rotation is normal after powering up a machine that had just shipped, because the equipment will find its home position on start up.Rotation will not cause injury due to the slip belt design; rotation is easily stopped if it hits an obstruction.The up motor button was pressed and the machine began to move up; the down motor button was pressed and the machine moved down.Preliminary observation is that the screwmotor was working fine and that this machine did not fall.During the initial check, it was observed that a screwmotor warning decal had been placed on the control panel side plastic cover of the machine.Once the initial observations were complete, power was turned off and the screwmotor was removed from the machine for a closer inspection.Once power was applied to the screwmotor assembly the nut assembly was able to be threaded off of the shaft.The t-nut assembly has all of the treads intact and was operating normally.This screwmotor assembly did not appear to have failed.While doing the investigation on the screwmotor additional observations were made about this returned machine.This machine was very dusty; it appears it had been sitting for an extended period of time.The exposure switch on the machine had been replaced with a non-panoramic replacement parts.It appears this machine was serviced by a non-factory trained panoramic technician.When trying to remove the screwmotor it became necessary to undo some wiring routed incorrectly by whoever was servicing this equipment.They had incorrectly routed the limit switch cabling over the electric plate assembly instead of underneath like factory routing and then preceded to weave the cabling between other cable assemblies.It appears at some point during their attempt to reconnect this limit switch cable they lost track of the connections because one of the wires was stripped (assume to find the hot wire) and wrapped in electrical tape.

Event Description

A recall for this issue was initiated on 23-apr-2015.An email was received by our sales team on 05/09/2016.In the email, a dentist requested his pc1000 machine be removed.He stated the request was due to a malfunction with the machine resulting in a near death incident.The date of the incident was not available.No one was injured or sought medical attention.

• Brand Name: PANCORAMIC 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: 5926686
• MDR Text Key: 53901144
• Report Number: 1832462-2016-00010
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K870236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 800724-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2001
• 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