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

Model Number PREVA

Device Problems Detachment Of Device Component (1104); Installation-Related Problem (2965)

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

Event Date 09/29/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, a dealership ((b)(6)) reported to midmark that a preva unit (serial no.(b)(4)) installed at (b)(6), separated from the wall.At the time of reporting, the dealership had already re-enforced and repaired the wall and had replaced the unit with one from factory stock.The dealership provided to midmark photographs of the damaged wall and stated that no person was injured when the unit separated from the wall.Investigation by the dealer field technician revealed that the affected unit had been improperly installed.The preva installation manual (00-02-1577) states that plywood is not an acceptable attachment material, and affected unit was attached to the wall using a plywood backer board.The preva installation manual also recommends that wooden studs be located initially by a stud finder device, then visually verified by opening the wall.The affected unit was attached using there screws, two of which were bolted into wooden studs and one inadvertently bolted into a gap between two studs.The use of plywood and inadequate location of studs led to insufficient attachment of the preva unit to the wall.

• Brand Name: PROGENY PREVA
• Type of Device: UNIT, X-RAY, EXTRORAL WITH TIMER
• Manufacturer (Section D): MIDMARK CORP.; 675 heathrow dr.; lincolnshire IL 60069
• Manufacturer Contact: nataliya khutorna ; 675 heathrow dr.; lincolnshire, IL 60069 ; 8474159760
• MDR Report Key: 4219247
• MDR Text Key: 22267133
• Report Number: 1423380-2014-00009
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PREVA
• Device Catalogue Number: DB74446
• Device Lot Number: P7017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2014
• 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