MAUDE Adverse Event Report: GCX CORPORATION MOUNTING BRACKET; STAND, INFUSION

Model Number 38532

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 08/16/2021

Event Type  malfunction  

Event Description

Mounting screws for the gcx mount for the masimo monitor with bar code scanner were missing, monitor could have fallen off the wall mount.

• Brand Name: MOUNTING BRACKET
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): GCX CORPORATION; 3875 cypress drive; petaluma CA 94954
• MDR Report Key: 12420974
• MDR Text Key: 269771146
• Report Number: 12420974
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 38532
• Device Catalogue Number: 38532
• Device Lot Number: 080320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1