MAUDE Adverse Event Report: GCX CORPORATION VHM SERIES VARIABLE HEIGHT MOUNT (WS01); STAND, INFUSION

Catalog Number VHM SERIES WALL MOUNT

Device Problem Unintended Arm Motion (1033)

Patient Problem Injury (2348)

Event Date 11/25/2016

Event Type  malfunction  

Event Description

Monitor dropped from locked position and hit staff member's head.The vhm articulating arm connected to the philips monitor lock lever released due to a internal gas spring which had lost its gas charge.In cases where the arm is left unused and unchecked for many months, gradual loss of pressure may not be noticed until the locking lever is released.Manufacturer response for articulating mount arm, vhm articulating mount arm for philips monitor (per site reporter).Gcx bulletin had been sent out to the identified owners.Primary childrens' hospital clinical engineering had not received notice.Philips had installed this mount with the monitors that primary had purchased from them, so primary was not identified as a owner but philips who had purchased for installation of their monitors in the units.Communication was not passed on.

• Brand Name: VHM SERIES VARIABLE HEIGHT MOUNT (WS01)
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): GCX CORPORATION; 3875 cypress drive; petaluma CA 94954
• MDR Report Key: 6345378
• MDR Text Key: 67854322
• Report Number: 6345378
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: VHM SERIES WALL MOUNT
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2017
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other