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

Model Number ARD568423010C

Device Problems Detachment of Device or Device Component (2907); Misassembled During Installation (4049)

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

Event Date 10/12/2022

Event Type  malfunction  

Event Description

On 12th october, 2022 getinge became aware of an issue with one of surgical lights - powerled.It was stated the upper fixation plate attached to the ceiling was not mounted properly.The nut was missing from the bolt of the upper fixation plate causing uneven connection.The plate was not a getinge product and was not installed by getinge.There was no injury reported, however, we decided to report the issue in abundance of caution as this incorrect installation could lead to fall of the device and as a result of that, could lead to serious injury.

Manufacturer Narrative

The initial reporter is operating theatre coordinator.Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Manufacturer Narrative

Getinge became aware of an issue with one of the surgical lights - powerled.It was stated the upper fixation plate attached to the ceiling was not mounted properly.The nut was missing from the bolt of the upper fixation plate causing uneven connection.The plate was not a getinge product and was not installed by getinge.There was no injury reported, however, we decided to report the issue in an abundance of caution as this incorrect installation could lead to the fall of the device and as a result of that, could lead to serious injury.According to the information provided by the getinge service technician, the device was repaired by the re-adjustment and it passed the full function check so it was released for further usage.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event due to the incorrect installation.The device was being used for patient treatment when the issue occurred.Comparing the number of claimed devices to the install base, we conclude that the failure ratio is very low.A root cause analysis was performed by the manufacturer¿s subject matter expert and it was concluded that the root cause of the issue is that the non-getinge part was installed and the installation was not done by the getinge.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

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

Manufacturer Narrative

The correction of d4 catalog # deems required.This is based on the internal evaluation.Previous d4 catalog # ard568423010c.Corrected d4 catalog # ard568370938 / ard568350933.According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.

Event Description

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

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 15672123
• MDR Text Key: 304894317
• Report Number: 9710055-2022-00439
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568423010C
• Device Catalogue Number: ARD568370938 / ARD568350933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1