MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG VIDIAPORT; VIDIAPORT HOLDER 3000, MONITOR DUO

Model Number 1714803

Device Problems Fracture (1260); Material Integrity Problem (2978); Physical Property Issue (3008)

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

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

The affected parts were exchanged and returned for further investigation.An external investigation identified some material faults which reduced the stability of the plastic part and led to a fatigue fracture.The manufacturer of the monitor bracket has changed the material used in these brackets and the affected parts were manufactured prior to this change.

Event Description

While adjusting the monitor on a trumpf medical vidiaport holder, the joint broke.No patient impact was reported.

• Brand Name: VIDIAPORT
• Type of Device: VIDIAPORT HOLDER 3000, MONITOR DUO
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318 ; 6715864140
• MDR Report Key: 6638414
• MDR Text Key: 77708351
• Report Number: 9681407-2017-00018
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K061317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1714803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2013
• 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