MAUDE Adverse Event Report: IHB SKYTRON; SKYBOOM

Model Number 110 SERIES

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2015

Event Type  malfunction  

Event Description

Hospital staff was maneuvering a monitor that is attached to a bracket on a skyboom, when the bracket broke and causing the monitor to fall.No injuries were reported.The arm that the bracket was attached was moved away from the surgical field and the cause was able to be completed.Skytron is currently investigation the issue.The product is planned to be returned for further evaluation.

• Brand Name: SKYTRON
• Type of Device: SKYBOOM
• Manufacturer (Section D): IHB; zwolle ; NL
• Manufacturer (Section G): SKYTRON, DIV. THE KMW GROUP, INC.; 5000 36th st., s.e.; grand rapids MI 49512
• Manufacturer Contact: 5000 36th st., s.e.; grand rapids, MI 49512
• MDR Report Key: 5197088
• MDR Text Key: 30331168
• Report Number: 1825014-2015-00047
• Device Sequence Number: 1
• Product Code: FTA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 110 SERIES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2015
• Distributor Facility Aware Date: 10/16/2015
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1