MAUDE Adverse Event Report: PANORAMIC PANORAMIC PC-1000, PANORAMIC X-RAY; DENTAL X-RAY

Model Number PC-1000

Device Problem Component Falling (1105)

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

Event Date 06/28/2014

Event Type  Injury  

Event Description

Total failure of screw motor assembly caused the entire x-ray tube and detector to fall to the floor.A patient was not in position at the time.During normal operation, the patient is positioned under this assembly.If it had failed with the patient in position, serious injury would have resulted.

• Brand Name: PANORAMIC PC-1000, PANORAMIC X-RAY
• Type of Device: DENTAL X-RAY
• Manufacturer (Section D): PANORAMIC; ft. wayne 46818
• MDR Report Key: 3927155
• MDR Text Key: 4669616
• Report Number: MW5037126
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2014

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: Health Professional
• Device Model Number: PC-1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability