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

Model Number PREVA

Device Problem Material Separation (1562)

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

Event Date 03/23/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, it was reported to (b)(6) technician that an x-ray unit (preva intraoral dental x-ray system, serial no.(b)(4)) began to separate from its wall mounting at a user facility in (b)(6).While at the facility, the technician tightened the screws to better secure the unit to the wall and reported to (b)(6) that he plans to relocate the machine at a future date.(b)(6) will be sending a letter to the dealer organization to remind them that the machine requires relocation to prevent future separation from the wall.No injuries were reported.At (b)(6) request, the technician agreed to return to the user facility to perform an on-site inspection of the mounting to determine the cause of separation.(b)(6) is currently waiting on the results on this inspection, and intends to submit a follow-up report if additional information becomes available.

• Brand Name: PREVA
• Type of Device: UNIT, X-RAY, EXTRAORAL WITH TIMER
• Manufacturer (Section D): MIDMARK CORP; 675 heathrow drive; lincolshire IL 60069
• Manufacturer Contact: adam foresman ; 675 heathrow drive; linconlnshire, IL 60069 ; 8474159739
• MDR Report Key: 4723475
• MDR Text Key: 21084706
• Report Number: 1423380-2015-00012
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• PMA/PMN Number: K043092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1