MAUDE Adverse Event Report: PHILIPS BURTON MEDICAL ALCKO LED EXAM LIGHT; LAMP, SURGICAL

Model Number MNS200

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Injury (2348)

Event Date 04/14/2015

Event Type  malfunction  

Event Description

Nurse was positioning exam light which is mounted to ceiling broke from arm attachment fell to floor hitting nurse and patient.Minor injury only to staff/patient.
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manufacturer response for ceiling mounted exam light, led exam light (per site reporter).
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coming to investigate and to install new exam light.

• Brand Name: ALCKO LED EXAM LIGHT
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): PHILIPS BURTON MEDICAL; 11500 melrose ave.; franklin park IL 60131
• MDR Report Key: 4794699
• MDR Text Key: 20127858
• Report Number: 4794699
• Device Sequence Number: 0
• Product Code: KZF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: MNS200
• Device Catalogue Number: MNS200-SC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2015
• Device Age: 2 YR
• Date Report to Manufacturer: 05/26/2015
• Patient Sequence Number: 0