MAUDE Adverse Event Report: PANORAMIC CORP. PANORAMIC X-RAY MODEL PC-1000

Model Number 800724-1

Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 11/07/2000

Event Type  Injury  

Event Description

" a recall for this issue was initiated on (b)(6) 2015.The machine is making a horrible noise going up and down.Exchanged machine.No injuries reported.

• Brand Name: PANORAMIC X-RAY MODEL PC-1000
• Type of Device: PC-1000
• Manufacturer (Section D): PANORAMIC CORP.; fort wayne IN
• Manufacturer Contact: 4321 goshen rd.; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 4881445
• MDR Text Key: 6059805
• Report Number: 1832462-2015-00038
• 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
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 800724-1
• Device Lot Number: 600 - 13885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2000
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/1995
• 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