MAUDE Adverse Event Report: PHILIPS BURTON AIM LED MEDICAL EXAMINATION LIGHT; AIM LED SINGLE CEILING LIGHT

Model Number ALEDSC

Device Problems Break (1069); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

Customer reported 8 of 17 collars have cracked over time and broken on their lights and one the head came off.No injuries reported.All 17 collars were replaced on aim led lights.Warning label was placed on the collars to prevent over torque force that could lead to collar crack.

Event Description

Customer reported 8 of 17 aim led collars have cracked over time and broken on their lights and one of the head lights came off.No injuries reported.

• Brand Name: AIM LED MEDICAL EXAMINATION LIGHT
• Type of Device: AIM LED SINGLE CEILING LIGHT
• Manufacturer (Section D): PHILIPS BURTON; 11500 melrose ave; franklin park IL 60131
• Manufacturer (Section G): PHILIPS BURTON; 11500 melrose ave; franklin park i IL 60131
• Manufacturer Contact: khalid nijmeh ; 11500 melrose ave; franklin park,, IL 60131 ; 8474510744
• MDR Report Key: 5708713
• MDR Text Key: 46888551
• Report Number: 3009542956-2016-00003
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Assistant
• Device Model Number: ALEDSC
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2016
• Initial Date FDA Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1