MAUDE Adverse Event Report: MAQUET SAS POWERLED II; LAMP, SURGICAL

Model Number ARDPWT229055A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 20th march, 2021 getinge became aware of an issue with powerled ii surgical light.As it was stated, installers of the equipment notched the rubber cap to fit the cap over the grounding screw.Over time, the grounding screw rubbed against the notch on the cap knocking it off onto the floor during a procedure with the patient on the table.There was no injury reported, however, we decided to report the issue based on the potential as it could lead to contamination of sterile field.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation the purpose of this submission is also to provide a correction of version or model # and catalog#.This is based on internal evaluation of available data.#d4 previous version or model #: ardpwt209001a.Corrected version or model #: ardpwt229055a.Previous catalog#: ardpwt209001a.Corrected catalog#: ardpwt229055a.

Manufacturer Narrative

Getinge became aware of an issue with powerled ii surgical light.As it was stated, installers of the equipment notched the rubber cap to fit the cap over the grounding screw.Over time, the grounding screw rubbed against the notch on the cap knocking it off onto the floor during a procedure with the patient on the table.There was no injury reported, however, we decided to report the issue based on the potential as it could lead to contamination of sterile field.The issue was temporarily resolved and new bumpers were ordered.It was established that when the event occurred, the surgical light did not meet its specification as bumper has detached and in this way device contributed to event.Event occurred when the device was being used for patient treatment.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.The detachment of the suspension cover was caused by an improper fitting due to the protrusion of earth fixing head screw.The installation manual im 01814 describes, for the us zone, the connection of the earth cable at the bottom of the suspension axle.For a standard suspensions the head of the screw must be placed outside of the axle hole and for a video suspension the head of the screw must be placed in the axle hole.The internal design of the standard suspension cover ard569204002 does not permit to place the screw head in the axle hole.The screw was probably mounted upside down during the installation, it appears that the protrusion of the earth fixing head screw restricted the fitting of the inner part of the cover in the suspension axle.The inner part of the cover was probably cut to avoid the contact with the protrusion of the head screw.To prevent any incident the installation manual im 01814 and the instruction for use ifu 01811 describes how to place the earth fixing screw, mentions that to secure the bumper, two screws can be added and mentions to check the hold of the suspension cover.We believe that all remaining devices are performing correctly in the market.Given the circumstances and after our review of complaint ratio behavior 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.The purpose of this submission is also to provide a correction of product code.This is based on internal evaluation of available data.#d4 previous product code.: fsa; corrected product code.: ftd.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: POWERLED II
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11551185
• MDR Text Key: 243129531
• Report Number: 9710055-2021-00107
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARDPWT229055A
• Device Catalogue Number: ARDPWT229055A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/12/2021
• Patient Sequence Number: 1