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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC PC 4000

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PANORAMIC CORPORATION PANORAMIC PC 4000 Back to Search Results
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.
 
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Brand NamePANORAMIC
Type of DevicePC 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 Key6475535
MDR Text Key72213451
Report Number1832462-2017-00006
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043557
Number of Events Reported1
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 Received04/10/2017
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/10/2017 Patient Sequence Number: 1
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