MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC; PC 4000

Device Problems Maintenance Does Not Comply To Manufacturers Recommendations (2974); Power Problem (3010)

Patient Problems Electric Shock (2554); No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2017

Event Type  Injury  

Event Description

The (b)(6) tech called in and said one of the staff members, (b)(6), got zapped.After calling the office and speaking to her, she stated that she went to power down the machine and felt the buzz.She said it was like when a child sticks their finger in a wall outlet.She had slight tingling in her arm for a couple hours.She also mentioned that they made a report at the office as well.She said she's fine.She just told her boss what happened and they called their tech in to investigate.Found out the power switch at the base of the machine was broken and per a previous case on (b)(6) 2016 this has been broken for some time.Quoted parts cost but the office never did the repair.Now someone got shocked while trying to press the switch.

• Brand Name: PANORAMIC
• Type of Device: PC 4000
• Manufacturer (Section D): PANORAMIC CORPORATION; 4321 goshen road; fort wayne IN 46818
• Manufacturer (Section G): PANORAMIC CORPORATION; 4321 goshen road; fort wayne IN 46818
• Manufacturer Contact: adrienne demland ; 4321 goshen road; fort wayne, IN 46818 ; 8006542027
• MDR Report Key: 6475535
• MDR Text Key: 72213451
• Report Number: 1832462-2017-00006
• Device Sequence Number: 1
• Product Code: EHD
• UDI-Device Identifier: 00862309000347
• UDI-Public: 00862309000347
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Assistant
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2012
• 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