MAUDE Adverse Event Report: PHILIPS BURTON GLEAMER , MEDICAL EXAMINATION LIGHT; GL30W

Model Number GL30W

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

Philips burton received an mdr report ((b)(4)) from fda by mail on feb 8th 2016 regarding (b)(6) staff member who was struck by a burton gleamer light on (b)(6) 2015.They stated "a staff member was preparing a room for patient.The mounted swing arm fell off the wall without being touched or moved, striking the staff member in the head and shoulder.She required shoulder x-ray, ice packs and ear exam.However, ultimately the injury was minor.Inspection of the lamp identified that the connector between the adjustable arm and the wall mount bracket had failed, and completely snapped off.Philips burton contacted the customer for farther investigation.The light was found to be more than 10 years old and no longer under warranty.Therefore, it is considered to be beyond its usable life.

Event Description

Philips burton received an mdr report ((b)(4)) by mail on feb 8th 2016.The report describes the event as: "a staff member was preparing a room for patient.The mounted swing arm fell off the wall without being touched or moved, striking the staff member in the head and shoulder.She required shoulder x-ray, ice packs and ear exam.However, ultimately the injury was minor.Inspection of the lamp identified that the connector between the adjustable arm and the wall mount bracket had failed, and completely snapped off.

• Brand Name: GLEAMER , MEDICAL EXAMINATION LIGHT
• Type of Device: GL30W
• Manufacturer (Section D): PHILIPS BURTON; 11500 melrose ave; franklin park IL 60131
• Manufacturer (Section G): PHILIPS BURTON; 11500 melrose ave; franklin park IL 60131
• Manufacturer Contact: khalid nijmeh ; 11500 melrose ave; franklin park, IL 60131 ; 8472888905
• MDR Report Key: 5582676
• MDR Text Key: 43446636
• Report Number: 3009542956-2016-00001
• 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: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: GL30W
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other