MAUDE Adverse Event Report: PHILIPS BURTON OUTPATIENT II MEDICAL EXAMINATION LIGHT; OP216SC

Model Number OP216SC

Device Problem Component Falling (1105)

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

Event Date 10/06/2015

Event Type  malfunction  

Event Description

Employee was moving the light into position above a pt on an exam table and it fell, the employee caught it with her chest, it didnot hit the pt.

• Brand Name: OUTPATIENT II MEDICAL EXAMINATION LIGHT
• Type of Device: OP216SC
• Manufacturer (Section D): PHILIPS BURTON; 11500 melrose ave; franklin park IL 60131
• Manufacturer (Section G): PHILIPS BURTON; 11500 melrose ave; franklin park IL 60131 0000
• Manufacturer Contact: khalid nijmeh ; 11500 melrose ave; franklin park, IL 60131 ; 8472888905
• MDR Report Key: 5252873
• MDR Text Key: 32288550
• Report Number: 3009542956-2015-00002
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: OP216SC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2012
• 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