MAUDE Adverse Event Report: YOUNG INNOVATIONS PANORAMIC CCD ENCOMPASS

Model Number 801413-1

Device Problems Electrical /Electronic Property Problem (1198); Fire (1245)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

The technician has tested wires to make sure there aren't any other short circuits with the machine.He replaced the capacitor board, tubehead, and cable 58.The machine is working now.(b)(4).

Event Description

The aps technician, (b)(6), was at the office working on the machine and replaced cable 58 on the machine.When the machine was powered on, the capacitor board started crackling and then burst into flames.The technician had to put the fire out with his sweater.The aps technician was not physically injured.

• Brand Name: PANORAMIC CCD ENCOMPASS
• Type of Device: CCD ENCOMPASS
• Manufacturer (Section D): YOUNG INNOVATIONS; 4321 goshen rd.; fort wayne IN 46818
• Manufacturer (Section G): YOUNG INNOVATIONS; 4321 goshen rd.; fort wayne IN 46818
• Manufacturer Contact: adrienne demland ; 4321 goshen rd.; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 7598029
• MDR Text Key: 111440770
• Report Number: 1832462-2018-00004
• Device Sequence Number: 1
• Product Code: MUH
• UDI-Device Identifier: 00862309000361
• UDI-Public: 00862309000361
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Service and Testing Personnel
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Model Number: 801413-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2014
• 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