MAUDE Adverse Event Report: STRYKER STRYKER; STRYKER STANDARD CART 240-099-011

Model Number 240-099-011

Device Problems Melted (1385); Smoking (1585); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2019

Event Type  malfunction  

Event Description

Nursing plugged in stryker video tower and a short time later white smoke was witnessed coming out of the outlet.Plug and outlet started sparking and was immediately unplugged.Prong from tower plug was noted to have melted off and was still inside wall outlet.

• Brand Name: STRYKER
• Type of Device: STRYKER STANDARD CART 240-099-011
• Manufacturer (Section D): STRYKER; 5900 optical ct; san jose CA 95138
• MDR Report Key: 9859863
• MDR Text Key: 184279269
• Report Number: 9859863
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 240-099-011
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2020
• Date Report to Manufacturer: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1