MAUDE Adverse Event Report: MAQUET SAS MAQUET X-TEN SURGICAL LIGHT LAMP, SURGICAL

Model Number ARD567801094

Device Problem Device Fell (4014)

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

Event Date 03/07/2019

Event Type  malfunction  

Event Description

The surgeon was positioning the surgical light when the light head fell off the spring arm. He was able to deflect the light head away from the patient as it fell. The patient was not injured during this event.

• Brand Name: MAQUET X-TEN SURGICAL LIGHT
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS
• MDR Report Key: 8416626
• MDR Text Key: 138816664
• Report Number: MW5084868
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ARD567801094
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 03/12/2019 Patient Sequence Number: 1