MAUDE Adverse Event Report: GCX CORPORATION SKYTRON; VHM WALL MOUNT NEW 8/20.3 EXT. EXTENSION ARM

Model Number H8-010-50-A

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

The vst accessory clamp was stripped where the gcx vhm monitor arm attaches to the screws.This was caused by an over adjustment of the 4 set screws that keep the gcx vhm monitor arm firmly attached to the vst clamp.The set screws were so firmly adjusted that they carved grooves into the stainless steel housing and then caused 2 of the set screws to be stripped and are unable to be removed as intended.This over adjustment in addition to trauma to the assembly as a whole is what caused the failure to occur.I was able to ensure that the malfunction did not effect the monitor or monitor wiring.The monitor still shows picture and functions properly.Or 20 sn (b)(4) i replaced the vst accessory clamp, (h8­300­39­a), on the vst.I attached the gcx mounting block for clamp, (h8­300­40­b) and secured a new gcx variable height arm, (h8­010­50­a), with down post kit, (h8­010­50­01).I attached the monitor and re­ran the cables and made the appropriate connections.I successfully tested the signal to the monitor and ensured it was secure.

Event Description

Skytron complaint number: (b)(4).A monitor and monitor bracket detached from the vst clamp that it mounts to.The vst accessory clamp was stripped where the gcx vhm monitor arm attaches to the screws.This was caused by an over adjustment of the 4 set screws that keep the gcx vhm monitor arm firmly attached to the vst clamp.The set screws were so firmly adjusted that they carved grooves into the stainless steel housing and then caused 2 of the set screws to be stripped and are unable to be removed as intended.This over adjustment in addition to trauma to the assembly as a whole is what caused the failure to occur.I was able to ensure that the malfunction did not effect the monitor or monitor wiring.The monitor still shows picture and functions properly.

• Brand Name: SKYTRON
• Type of Device: VHM WALL MOUNT NEW 8/20.3 EXT. EXTENSION ARM
• Manufacturer (Section D): GCX CORPORATION; 3875 cypress drive; petaluma CA 94954 5635
• MDR Report Key: 11147013
• MDR Text Key: 260816030
• Report Number: 1825014-2021-00003
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/11/2021

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: No Information
• Device Model Number: H8-010-50-A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2021
• Distributor Facility Aware Date: 10/26/2020
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1