MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SPRING ARM DISPLAY 23-30 MOX

Model Number G92756

Device Problems Structural Problem (2506); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that the monitor mount came down when the user tried to adjust the screen position.There were no health consequences reported neither for the patient nor the user.

Manufacturer Narrative

The investigation was based on the assessment of the available information including pictures of the affected device.Based on the investigation the reported issue could be verified and an old version of the locking element was identified as root cause of the reported event.This locking element did not engage sufficiently in the corresponding groove due to the deviating geometry.Furthermore, excessive material abrasion was caused as the spring arm locking element moved out of its seat and thereby damaged the adjacent pin geometry.If the connection between spring arm and display support fails, the affected display support system may fall.If the falling display support system is held by the electrical cable connections, it possibly changes into a pendulum movement.The affected display mount and its ac3000 locking element was replaced at the customer site.In 2013/14 a field safety corrective action to inform the user of the risk of using the old version of the locking element in a safety notice which clearly points out a replacement.This is the first occurrence after closure of the field action in japan.

Event Description

It was reported that the monitor mount came down when the user tried to adjust the screen position.There were no health consequences reported neither for the patient nor the user.

• Brand Name: SPRING ARM DISPLAY 23-30 MOX
• Type of Device: SPRING ARM
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11883017
• MDR Text Key: 255761377
• Report Number: 9611500-2021-00223
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

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: Health Professional
• Device Model Number: G92756
• Device Catalogue Number: G28350
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1