MAUDE Adverse Event Report: MIDMARK CORPORATION PREVA; UNIT, X-RAY, INTRAORAL

Model Number PREVA

Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2018

Event Type  malfunction  

Event Description

On 2/7/2018 it was reported to midmark by a service technician that an z-ray unit (preva, 76" reach, serial (b)(4)) separated from the wall in which it was secured.There were no injuries or contact with any persons as reported by the complainant.No other patient information has been disclosed.The unit mounting was visually inspected at the user facility and photographs were provided to midmark.There is evidence of wood splitting in the photographs provided.Per the questionnaire completed by technical support while on the initial call with the service technician, no installation manual was used for this installation.The preva unit (dom (b)(6) 2007) was mounted to the wall through drywall using a single stud mount.Per the questionnaire, the top lag bolt split the stud and came loose (unbroken) from the wall while the bottom lag bolt remained secured in the stud.The wall fasteners were not centered in the wall stud.No other surfaces at the location were damaged aside from the unit itself.Multiple attempts to contact the initial reporter went unanswered.Midmark technical support made attempts to contact the initial reporter on 2/7/2018, 2/19/2018, and 2/26/2018 with no response.On 3/6/2018, technical support contacted the customer directly to inquire as to the status of the unit.The customer informed midmark at that time that the unit has not yet been remounted at their location.No further information is available at this time.

• Brand Name: PREVA
• Type of Device: UNIT, X-RAY, INTRAORAL
• Manufacturer (Section D): MIDMARK CORPORATION; 675 heathrow drive; lincolnshire IL 60069
• Manufacturer Contact: adam foresman ; 675 heathrow drive; lincolnshire, IL 60069 ; 2242204329
• MDR Report Key: 7319042
• MDR Text Key: 102096792
• Report Number: 1423380-2018-00001
• Device Sequence Number: 1
• Product Code: EAP
• 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: distributor
• Reporter Occupation: Service Personnel
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PREVA
• Device Catalogue Number: P7017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2007
• 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