MAUDE Adverse Event Report: PHILIPS / BURTON MEDICAL, LLC BURTON OUTPATIENT II; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number 0224100

Device Problems Collapse (1099); Loose or Intermittent Connection (1371)

Patient Problem Laceration(s) (1946)

Event Date 08/20/2019

Event Type  Injury  

Event Description

Medical assistant was struck by flexible arm on burton outpatient ii light.The adjustment knob came loose and the articulating arm collapsed downward onto employee's head causing a laceration requiring 9 staples.Fda safety report id# (b)(4).

• Brand Name: BURTON OUTPATIENT II
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): PHILIPS / BURTON MEDICAL, LLC ; addison IL 60101
• MDR Report Key: 8949825
• MDR Text Key: 156321461
• Report Number: MW5089470
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0224100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other