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

Catalog Number ARD568350938

Device Problem Component Missing (2306)

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

Event Date 12/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue is being investigated by manufacturer.

Event Description

On 21th june, 2018 during investigation for the complaint (b)(4) it appeared that the issue described in the complaint (b)(4) should be reported to compenent authorities according to current approach.As stated in the complaint, the bumper was found removed from the bottom of main arm.The circumstances of the issue are unknown.(b)(4).

Event Description

Ref- tw # (b)(4); (b)(6).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074; exemption # e2018005.Getinge usa sales, llc 45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).Maquet sas became aware of an incident with a surgical light powerled device.As it was stated by the customer the bumper of a surgical light fell off during preparation to the surgery.The bumper part is used to cover the bottom of the main tube and access to cables inside the surgical light.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.In the time when the event occurred the device was not used for patient treatment.During the investigation it was found that the reported scenario has to date not lead to serious injury or worse, to death.As per performed tests the root cause of falling bumper is likely caused by several violent collisions with the cupolas, this can happen when the user is not being careful with moving the device arms and lights.To prevent any other cases, maquet sas recommends in powerled user manual 01581en ed.06 on page 40 that during the annual check which should be performed by an authorized technician the looseness of covers and caps must be checked.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.Shall continue to monitor for any further events of this nature and do not propose any further action.

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7706177
• MDR Text Key: 114808303
• Report Number: 9710055-2018-00058
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568350938
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Date Manufacturer Received: 12/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1