MAUDE Adverse Event Report: MIDMARK CORPORATION PROGENY PREVA; UNIT, X-RY, EXTRAORAL WITH TIMER

Model Number PREVA

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Smoking (1585)

Patient Problem Electric Shock (2554)

Event Date 09/09/2014

Event Type  malfunction  

Event Description

A dental office reported to midmark on (b)(6) 2014 that the office manager received electrical shock when turning on a preva x-ray nit, serial number (b)(4).The dental office reported to midmark that the shock took place about 6 months ago.The office manager of the dental office reported that she received shock on (b)(6) 2014 when she turned on the unit in the morning and observed smoke came out of the opening of the switch.The unit was turned off immediately and turned on again to see if it would do the same.The machine did not shock or release any smoke after it was restarted.The office manager stated that her hands and the machine were completely dry.She felt the shock on her finger, and the other hand was on her side without touching any metal parts.The floor was a hardwood floor.The machine was usually dusted off with a dry rag and a tube head covered with a plastic bag, which was replaced with every patient.The dental office contacted the dealer for service 6 months ago.The dealer technician tested the machine and stated that the machine was working fine.No part was replaced by the dealer technician.On (b)(6) 2014, the dental office also reported that the dental office on (b)(6) 2014 that no one was injured or sought for medical intervention as a result of the shock.

• Brand Name: PROGENY PREVA
• Type of Device: UNIT, X-RY, EXTRAORAL WITH TIMER
• Manufacturer (Section D): MIDMARK CORPORATION; 675 heathrow drive; lincolnshire IL 60069
• Manufacturer (Section G): MIDMARK CORPORATION; 675 heathrow drive; lincolnshire IL 60069
• Manufacturer Contact: peng lin ; 675 heathrow drive; lincolnshire, IL 60065 ; 8474159787
• MDR Report Key: 4168346
• MDR Text Key: 5020189
• Report Number: 1423380-2014-00008
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PREVA
• Device Catalogue Number: P7017
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2010
• 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