MAUDE Adverse Event Report: STRYKER CORP. BERCHTOLD CHROMOPHARE; LIGHT, SURGICAL, CEILING MOUNTED

Model Number 650

Device Problems Device Operates Differently Than Expected (2913); Light Interference (2972); Moisture or Humidity Problem (2986)

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

Event Date 04/04/2017

Event Type  malfunction  

Event Description

The stryker boom lights in the o.R.Have been shorting out.The cause seems to be that moisture gets into the joints of the arms and head of the fixture and shorts out the connectors that bring the power to the fixture.

• Brand Name: BERCHTOLD CHROMOPHARE
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): STRYKER CORP.; 1410 lakeside pkwy; ste. 100; flower mound TX 75028
• MDR Report Key: 6507028
• MDR Text Key: 73254907
• Report Number: 6507028
• Device Sequence Number: 1
• Product Code: FSY
• 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: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 650
• Other Device ID Number: 201315
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2017
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2017
• 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