MAUDE Adverse Event Report: PANORAMIC CORP. PANORAMIC X-RAY MODEL LASER-1000; PC-1000/LASER1000

Model Number 800724-3

Device Problems Nonstandard Device (1420); Failure of Device to Self-Test (2937)

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

Event Date 05/15/2003

Event Type  Injury  

Event Description

A recall for this issue was initiated on (b)(6) 2015.Machine was being serviced and fell.No injuries.

• Brand Name: PANORAMIC X-RAY MODEL LASER-1000
• Type of Device: PC-1000/LASER1000
• Manufacturer (Section D): PANORAMIC CORP.; fort wayne IN
• Manufacturer Contact: 4321 goshen rd.; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 4881474
• MDR Text Key: 5862435
• Report Number: 1832462-2015-00028
• 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: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/09/2015

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: Other
• 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: 05/15/2003
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/1999
• 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