MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z.O.O. MDT CASTLE LIGHTS; LIGHT SURGICAL CEILING MOUNTED.

Model Number 516851

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Injury (2348)

Event Date 10/08/2018

Event Type  malfunction  

Event Description

After the time out, and during positioning of the patient, the overhead surgical light disconnected from the ceiling mount, falling and coming in contact with 2 members of the surgical team and the patient.Upon examination of the light it appears that the teeth of the mount were stripped out, which allowed the light to fall.Fluoroscopy performed with no obvious injuries noted to the patient.Patient transferred to ed via ems and examined and found to be uninjured.One member of the surgical team was found to have a sprained shoulder, otherwise surgical team unharmed.(b)(4).

• Brand Name: MDT CASTLE LIGHTS
• Type of Device: LIGHT SURGICAL CEILING MOUNTED.
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z.O.O.
• MDR Report Key: 7999514
• MDR Text Key: 125277688
• Report Number: MW5080768
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 516851
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 16 YR