MAUDE Adverse Event Report: RICHARD WOLF GMBH EXTENSION ARM, 50CM; SUPPORT ARM

Model Number 32114.453

Device Problem Component Falling (1105)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

Photo of monitor, bracket and cart submitted.Investigation/evaluation currently in process.(b)(4) considers this report open, follow up report to be submitted once investigation is complete.

Event Description

A monitor fell off its bracket striking a member of the staff on the shoulder while she was trying to position the monitor.No patient involvement.

Manufacturer Narrative

The extension arm was affected by a field safety corrective action (fsca) in 2013.Review of the documentation of the fsca from 2013 found a holder plate was mounted on the device in question at (b)(6) in 2013.Facility provided rw(b)(4) a photo of dropped monitor and the holder plate appeared to be missing.Absent of holder plate was confirmed once device was returned for investigation.Rw (b)(4) is unable to determine who removed plate, when it was removed or the reason for removing the plate.There have been no similar issues on (b)(4) extension arms with mounted holder plates since fsca in 2013.From our point of view there is no doubt about the effectiveness of the corrective action in 2013.(b)(4) considers this report to be closed.If any additional information is received concerning this event, an additional follow up report will be provided.(b)(4).

• Brand Name: EXTENSION ARM, 50CM
• Type of Device: SUPPORT ARM
• Manufacturer (Section D): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; 32 pforzheimer street; knittlingen, 75438 ; GM 75438 ; 043351013
• MDR Report Key: 5481926
• MDR Text Key: 40031259
• Report Number: 9611102-2016-00002
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 32114.453
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other