MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG DUAL FLAT PANEL MONITOR BRACKET ASM.; DUAL FLAT PANEL (FP) YOKE SUSPENSION

Catalog Number 106538

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

It was reported that the monitor is allegedly loose from the boom.The investigation on the device is anticipated, but not yet begun.When stryker can inspect the product, a supplemental will be filed to include the investigation results.There was no injury or adverse consequence reported.

Event Description

It was reported that the monitor is allegedly loose from the boom.There was no injury or adverse consequence reported.

Manufacturer Narrative

A stryker field service technician(sfst) arrived on site for investigation.The sfst found the dual flat panel yoke was no longer connected to the suspension spring arm.The site stated that the dual flat panel yoke was always "tight" and extremely hard to turn.It is their opinion that, over the years, the stress from the staff forcefully moving the yoke has caused the failure.From the disconnected dual flat panel yoke it appeared that an impact had occurred at some point in its life which bent the center support of the yoke and eventually caused the failure.The suspected root cause of the failure is misuse.A new dual flat panel yoke was installed at the site.This yoke operates as expected and has no issues.

Event Description

It was reported that the monitor is allegedly loose from the boom.The was no injury or adverse consequence reported.

• Brand Name: DUAL FLAT PANEL MONITOR BRACKET ASM.
• Type of Device: DUAL FLAT PANEL (FP) YOKE SUSPENSION
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532
• Manufacturer (Section G): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532
• Manufacturer Contact: volker hornscheidt ; ludwigstaler strasse 25; tuttlingen 78532 ; 74611810
• MDR Report Key: 6019295
• MDR Text Key: 57575609
• Report Number: 0008010153-2016-00093
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 106538
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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