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

Model Number 800724-1

Device Problems Component Falling (1105); Nonstandard Device (1420); Device Slipped (1584); Noise, Audible (3273)

Patient Problems Pain (1994); Neck Pain (2433)

Event Date 09/23/2009

Event Type  Injury  

Event Description

A recall for this issue was initiated on (b)(4) 2015.Panoramic x-ray machine slipped and fell and struck a patient.This patient initially complained of his neck hurting but later said his neck was fine and only had some pain in his lower back.They took him to the hospital via ems for precautionary reasons.The individual using the machine was lowering the unit from an adult patient to the child.The patient was not biting down on the bite guard nor was the child positioned on the chinrest.According to the doctor, when the machine was being lowered it made a loud noise then it slipped.

Manufacturer Narrative

Dental office did not provide further details on patient.(b)(4).

• 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: 4806069
• MDR Text Key: 5920503
• Report Number: 1832462-2015-00001
• 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: Repair
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 800724-1
• Device Lot Number: 6000-13885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2009
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2001
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 12 YR