MAUDE Adverse Event Report: MIDMARK CORPORATION PREVA; PREVA, 76" REACH

Model Number PREVA, 76" REACH

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 it was reported to midmark by a dealer technician that an x-ray unit (preva, 76" reach; serial number (b)(4) separated from the wall on which it was secured.There were no injuries to patients or facility personnel and no damage to property.The unit mounting was visually inspected at the user facility by the dealer technician and photographs were recieved by the midmark technical service group.After inspection of the mounting apparatus and mounting location, it was concluded by the technician that the structure on which the device was originally installed was plywood backing and not on a wood drywall stud or equivalent wall support, as specified on the midmark installation manual.The dealer technician also confirmed there was evidence of wood split but was not able to provide adidtional information as to what the thickness of the plywood backing was.It is unknown if the installation manual or installation template were used at the time of initial installation.No further information from the original installation could be retrieved since the original installer is no longer working with the dealer.

• Brand Name: PREVA
• Type of Device: PREVA, 76" REACH
• Manufacturer (Section D): MIDMARK CORPORATION; 1001 asbury dr; buffalo grove IL 66089
• Manufacturer Contact: kathy baughman ; 1001 asbury dr; buffalo grove, IL 60089 ; 8474159800
• MDR Report Key: 14489096
• MDR Text Key: 300374401
• Report Number: 1423380-2022-00001
• Device Sequence Number: 1
• Product Code: EAP
• Combination Product (y/n): Y
• 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: 505
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PREVA, 76" REACH
• Device Catalogue Number: P7017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1