MAUDE Adverse Event Report: STRYKER COMMUNICATIONS, INC CHROMOPHARE; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number D650P

Device Problem Unintended Movement (3026)

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

Event Date 05/08/2018

Event Type  malfunction  

Event Description

Or operating light in the room is drifting so much, that a medical student had to hold it still while surgeon operated.We then stabilized it against an extra iv pole however this is a continuing issue.

• Brand Name: CHROMOPHARE
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): STRYKER COMMUNICATIONS, INC; 571 silveron blvd.; flower mound TX 75028
• MDR Report Key: 7577421
• MDR Text Key: 110338710
• Report Number: 7577421
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: D650P
• Device Catalogue Number: 32909
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1