MAUDE Adverse Event Report: STYKER IMS

Model Number SK28-SYS E 1325059

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

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

Event Date 06/20/2014

Event Type  malfunction  

Event Description

Emergency laparoscopic appendectomy; during case had equipment failure.Had sudden loss of visual on overhead screens, received color bar coding and message that said "system error".Powered down info management system visuals would not return after several attempts and trouble shooting.

• Brand Name: IMS
• Type of Device: IMS
• Manufacturer (Section D): STYKER
• MDR Report Key: 3901778
• MDR Text Key: 21875951
• Report Number: MW5036870
• Device Sequence Number: 1
• Product Code: DQK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SK28-SYS E 1325059
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR