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

Model Number ARD568330933G

Device Problems Grounding Malfunction (1271); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021 getinge became aware of an issues with one of surgical lights - powerled.The lock nuts were missing from anchorage, the plastic cap and the retaining ring was missing from the spring arm and the surgical light was not grounded.We decided to report the issues in abundance of caution as missing of parts could cause fall of device or parts of device and it may cause contamination or injury and the lack of grounding could cause electrical shock.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The correction of d4 catalog #, d4 version od model #, d4 serial # and h4 manufacture date deems required.This is based on the internal evaluation.Previous d4 catalog #, d4 version od model #: ard567201356.Corrected d4 catalog #, d4 version od model #: ard568330933g.Previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6).Previous h4 manufacture date: 2017-10-05.Corrected h4 manufacture date: 2016-11-30.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.

Manufacturer Narrative

Getinge became aware of issues with one of surgical lights - powerled.The lock nuts were missing from anchorage, the plastic cap and the retaining ring was missing from the spring arm and the surgical light was not grounded.We decided to report the issues in abundance of caution as missing of parts could cause fall of device or parts of device and it may cause contamination or injury and the lack of grounding could cause electrical shock.Device was repaired and light was returned to use.It was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification and it contributed to the event.There is no information if the device was or was not being used for patient treatment at the time when the event occurred.When reviewing similar reportable events for the same device type, we have been able to confirm that, to the best of our knowledge, the investigated issues have never led to serious injury or worse.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the complaint rate is: very low for missing grounding, missing spring arm¿s cap, missing nuts on ceiling mounting and low for lack/faulty spring arm¿s retaining ring.The maquet technician has provided a detailed report on the status of this installation.After subject matter expert at manufacturer¿s evaluation it was stated that a lot of mistakes were made during this installation.(eg: missing of the safety ring, bending of dust covers, incorrect adjustment of the verticality, ¿) it can be concluded that the root cause of this issue is an incorrect installation by an untrained or a non-authorized personnel.Manfacturer recommends following user manual for powerled (ifu nu_powerled_01581 ed.09) and points out that installation, maintenance and decommissioning operations must be performed by trained personnel, approved by getinge.As per installation manual for powerled (ni_powerled_01584 ed.08), maquet sas points out the following: anyone not trained in installation, maintenance or decommissioning operations is exposed to the risk of injury or electric shock.Installation, maintenance and decommissioning of the device or components of the device must be performed by a getinge technician or a getinge-trained service technician.Besides, it is recommended to check all the installations which have been performed by the company who made powerled installation which was involved in the event (kröger systemtechnik), in order to verify that no other installation error was made.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident would have been avoided.

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: 13257254
• MDR Text Key: 283812508
• Report Number: 9710055-2022-00012
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568330933G
• Device Catalogue Number: ARD568330933G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 01/25/2022; 03/10/2022
• Supplement Dates FDA Received: 02/18/2022; 03/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1