MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED; ILED TRIO/QUAD

Model Number ILED 5K ALC+

Device Problems Device Maintenance Issue (1379); Device Issue (2379); Facilities Issue (2935); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

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

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

The use of prohibited cleaning agents with chlorine can damage powder coat surfaces.Corrosion that occurs and over time (months to years) spreads under the coating and lifts up the powder coating.Agitation (wipe down / collision) can cause powder coating to fall off.Product user manuals provide a list of agents which are chemical compatibility tested and approved by trumpf medical for cleaning and disinfecting.

Event Description

Trumpf medical was informed by a customer that paint from the surface of a surgical light was chipping with risk of falling off.

Manufacturer Narrative

The affected device was replaced at the facility.The returned, defective parts were investigated and evaluated.Our investigation has identified steps in the manufacturing process which combined with non-approved cleaners can lead to the paint chipping.The damage to the painted surfaces usually does not develop suddenly, but develops over time.The instructions for use state that the devices must be checked for proper condition prior to each use.Damaged devices must not be used.If damage to the surface coating is recognized and removed, there is no danger to the patient.The surface coating process will be updated to include additional testing and verification.

• Brand Name: ILED
• Type of Device: ILED TRIO/QUAD
• 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: 6243365
• MDR Text Key: 65052325
• Report Number: 9681407-2017-00004
• 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
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ILED 5K ALC+
• Device Catalogue Number: 4028310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2012
• 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