MAUDE Adverse Event Report: PANORAMIC CORP. PANORAMIC X-RAY MODEL LASER-1000; PC-1000/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 Type  malfunction  

Event Description

Office was informed via telephone of the recall and advised to cease usage of machine until repairs were done.Technician arrived to service machine, began to lower machine and machine dropped two feet.

• Brand Name: PANORAMIC X-RAY MODEL LASER-1000
• Type of Device: PC-1000/LASER 1000
• Manufacturer (Section D): PANORAMIC CORP.; 4321 goshen rd.; fort wayne IN 46818
• Manufacturer (Section G): PANORAMIC CORP.; 4321 goshen rd.; fort wayne IN 46818
• Manufacturer Contact: david woods ; 4321 goshen rd.; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 5249536
• MDR Text Key: 32264876
• Report Number: 1832462-2015-00065
• 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: other
• Reporter Occupation: Service Personnel
• Remedial Action: Repair
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 800724-3
• Device Lot Number: 6000-13885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2002
• 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): Required Intervention