MAUDE Adverse Event Report: MAQUET SAS PWD700SF; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number ARD568370901

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided after investigation result.

Event Description

On the 21th of april maquet sas became aware of an incident with powerled device.Customer reported that the ambient led module is becoming detached from the light.The ambient led module is the old manufacturing style hard plastic, not the newer silicon style.There was no patient involvement and no person claiming to be endangered.Reference to (b)(4).

Manufacturer Narrative

Maquet sas received customer complaint where, as stated, the issue with led illumination occurred and moreover ambient led module detached from the lighthead.Investigation on the issue was performed.Illumination on powerled devices is created by a special optical system.This system contains up to 168 led light sources located in the modules.User manual for powerled devices (01581en07) include troubleshooting information.Mentioned table includes situation when ¿a group of leds or one led does not come on and it clearly states that the likely cause is connected with the defective led board or led or with wrong communication with the led board.No matter which cause is right in case the customer should call maquet¿s technical department depending on the period of time when the device is used the led module could fail and this issue could be recognized as a normal wear, however detachment of the ambient led module has been established and connected ongoing field action (msa/2014/002/iu) which has been launched on 31st march 2014.The change which has been announced in nit220 released on 12nd march 2014.Investigated issue has been covered with the fsca and the failed device was listed as a device under this field action, however at the time of the event a changes had not been performed yet.Old version of the ambient led module was made of pmma (poly(methyl methacrylate) and has a 4 clipping system (called fixing tabs) which after a few times of ambient module replacement could broke.According to nit220 the root cause of the failure was established as a: assembly difficulties at maquet sas, leading to the fixing tabs to break or to be deteriorated.Dimension problems in the purchased parts.Pmma material not flexible enough to avoid breakage.Moreover it has been found that cleaning methods and agents could increase the probability of occurrence to this kind of failure.It was concluded that if the ambient light module fastening is detected as defective it should be replaced with the new one.When the event took place the device was not up to its specification and it has contributed to the outcomes of the event.No injuries have been reported according to the failure.However we report this case in abundance of caution.

Event Description

Reference to # (b)(4).

• Brand Name: PWD700SF
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): FREDERIC LELEU - MAQUET SAS; parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; FR 45074
• Manufacturer Contact: parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; 0332382587
• MDR Report Key: 6574970
• MDR Text Key: 75626598
• Report Number: 9710055-2017-00035
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568370901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1