MAUDE Adverse Event Report: BERCHTOLD HOLDING GMBH - STRYKER CHROMOPHARE F300; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number CE2863075

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 07/16/2019

Event Type  malfunction  

Event Description

While performing a c-section on a patient, the surgical light control panel turned off, not allowing the user to control intensity or light color changes.The control panel is installed on the wall and it is a digital touch screen panel.The operating room (or) light continues to work but the surgeon has to control the unit from the light itself, not allowing the operating room tech to control the light for the wall.To fix the problem, the control panel needs to be detached from the wall to remove and re-install the power plug from the device to create a boot-up session which takes up to 5 minutes.Manufacturer response for device, medical examination, ac powered, chromophare f300 (per site reporter) manufacturer is looking into the issue.

• Brand Name: CHROMOPHARE F300
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): BERCHTOLD HOLDING GMBH - STRYKER; 2825 airview boulevard; kalamazoo MI 49002
• MDR Report Key: 8830658
• MDR Text Key: 152327369
• Report Number: 8830658
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CE2863075
• Device Catalogue Number: CE 2863075
• 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: 07/18/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1