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

Model Number PREVA

Device Problems Component Falling (1105); Fracture (1260); Mechanical Problem (1384)

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

Event Date 05/26/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, it was reported to midmark that an x-ray unit (preva intraoral dental x-ray system, serial number (b)(4)) separated from its wall mounting at a user facility in (b)(6).A dealer technician was installing the x-ray unit, and while extending the arm during testing, one of the two fasteners (long socket cap screws) that bolt the control unit to the wall plate fractured, causing the control unit to rotate sideways and the device to fall to the ground.No injuries were reported.Photos of the incident were provided to midmark by the user facility, and the unit was re-installed with new fasteners.The failed fastener was returned to midmark for evaluation.

• Brand Name: PREVA
• Type of Device: UNIT, X-RAY, EXTRAORAL WITH TIMER,
• Manufacturer (Section D): MIDMARK CORPORATION; 675 heathrow dr.; lincolnshire, il 60069, us 60069
• Manufacturer Contact: adam foresman ; 675 heathrow drive; lincolnshire, IL 60069 ; 8474159739
• MDR Report Key: 4865125
• MDR Text Key: 17632435
• Report Number: 1423380-2015-00016
• 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,Distributor
• Reporter Occupation: Service and Testing Personnel
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: PREVA
• Device Catalogue Number: P7017-P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1