MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT 1000; T1000 EXAM LIGHT

Model Number T10000

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Device Issue (2379)

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

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

The trumpf service technician found the clip that holds the light head to the lamp head swing arm was missing.The technician replaced the clip and tightened the plastic spacer.Previous trumpf servicing activity completed on 04/03/17 involved the replacement of the lamp head swing arm.It is possible that the clip was not installed during this activity.The light is now tightly secured.

Event Description

A nurse was moving the t1000 exam light lamp head when it became dislodged from the cardanic.The nurse caught the lamp head & it did not strike the floor.There was no procedure in progress at the time.No patient impact or injury.

• Brand Name: TRULIGHT 1000
• Type of Device: T1000 EXAM LIGHT
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; 07318 saalfeld, ; GM
• Manufacturer Contact: steffen ulbrich ; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318 ; 6715864140
• MDR Report Key: 6579798
• MDR Text Key: 75732193
• Report Number: 9681407-2017-00017
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T10000
• Device Catalogue Number: 4058110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1