MAUDE Adverse Event Report: BURTON MEDICAL LLC AIM 50; LIGHT, SURGICAL, CEILING MOUNTED

Device Problems Electrical /Electronic Property Problem (1198); Connection Problem (2900)

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

Event Date 09/05/2017

Event Type  malfunction  

Event Description

Here is a general overview of the issue that we have experienced with the medical exam lights in the wound clinic.We have made multiple repairs to a specific electrical connection where the light fixture meets the arm.At this connection (which is made by a molex connector) there is a complete meltdown causing failure of the light fixture.I spoke with a technician for (b)(4) about the issue and he stated they have run into this issue and have since developed a new arm for the electrical connection.I feel that (b)(4) needs to provide us with the retrofit kit to make these lights both compliant and safe for the end user.As per my conversation with technician- he wasn't willing to absorb the cost of retrofit replacement even when these issues happened under original warranty.In my opinion these lights pose a safety hazard to staff and patients and should be taken out of service if we cannot come to a solution for the proper repair.I feel that we have formed a good baseline over the years- we have serviced these fixtures, so that if we can get some assistance from (b)(4) these lights are not a safe and reliable fixture to have in our facility.Manufacturer response for philips burton aim 50 a50sc unit, (brand not provided) (per site reporter).The issues are with the exam light itself and not the bulb.We've run into several dead ends trying to escalate this.We have contacted the manufacturer numerous times.I completed a midas 4 months ago.

• Brand Name: AIM 50
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): BURTON MEDICAL LLC; 2300 w windsor court ste c; addison IL 60101
• MDR Report Key: 7292045
• MDR Text Key: 100816536
• Report Number: 7292045
• 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: Patient
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: A50SC
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2018
• Event Location: Other
• Date Report to Manufacturer: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTHER, FIXED AS DIRECTED BY MANUFACTURER