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

Device Problems Component Falling (1105); Device Damaged by Another Device (2915)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue is still being investigated by manufacturing site.

Event Description

On (b)(6) 2018 maquet sas became aware of an incident with one of surgical lights-powerled.As it was stated by technician, one of the spring arms collided with fire detector on the ceiling.As a result the detector fell off on the field in pre-operating.There is no injury reported however we decided to report the issue in abundance of caution.Manufacturer reference number: 2018-59340.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Maquet sas became aware of an incident with a surgical light powerled device.As it was stated by technician, one of the spring arms collided with fire detector on the ceiling.As a result the detector fell off on the field in pre-operating.There is no injury reported however we decided to report the issue in abundance of caution and based on the potential as any unexpected movement of the device might cause an injury and any object falling into the sterile field might cause a contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.At the time when the event occurred the device was being used for patient treatment.During the investigation it was found that the reported scenario has never lead to serious injury or worse, to death.The complaint is considered to be first registered within last 5 years that refers to spring arm hitting the fire detector of the powerled device.We have approximately 34355 powerled devices on the market and only one complaint reported for this issue, which makes a low occurrence rate.The device has been recognized as powerled device with serial number (b)(4) and defective part number ard568370937.The manufacturing date of the device is (b)(6) 2012 based on the performed investigation we have concluded that this incident occurred due to incorrect mechanical adjustment of the top stop of the spring arm during installation process.What is more, in the powerled installation manual 01584en ed.05 page 66 there is an information how to adjust the top stop of the spring arm.Unfortunately, with the limited information available it became unknown when the installation had place and who performed this activity.Given the circumstances and the fact that this is the first complaint of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time getinge (b)(4) (importer) is submitting this report on behalf of 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.(b)(4).

Event Description

Manufacturer reference number (b)(4).

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7529430
• MDR Text Key: 109122634
• Report Number: 9710055-2018-00031
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1