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

Model Number ARDPWT229030A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2022

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) 2022 getinge became aware of an issue with one of surgical lights powerled ii.It was stated that the dome detached from the spring arm during cleaning.Due to the issue the cleaner has a problem with her wrist.We decided to report the issue based on potential as any parts falling on a person could lead to serious injury.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated that the dome detached from the spring arm during cleaning.Due to the issue the cleaner complained of a bad wrist and went to the emergency room to be examined.According to the analysis, nothing was broken.We decided to report the issue based on potential as any parts falling on a person could lead to serious injury.Based on the information collected, it was established that when the event occurred, the surgical lights did not meet its specification, since detachment of headlight could be considered as technical deficiency, and in this way devices contributed to event.Claimed device was not used for patient treatment when the event took place.When reviewing reportable events for this type of issues we were able to establish that the received incident is occurring at a very low ratio.Moreover, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Based on the technical analysis loose spring arm safety sleeve is due to the loosening of the safety screw because of an incorrect initial tightening or a lack of inspection during the installation or the maintenance.To prevent the loosening and the absence of the screw, the installation manual describes how to assemble the safety sleeve, the maintenance manual mentions to check for any loose covers and the service protocol included in this document mentions to check the presence of the spring arm safety sleeve and the presence of the fixing screw.The loosening and the absence of the safety sleeve screw can lead to the translation of the safety sleeve causing the fall of the light head.To prevent the risk of the separation of the light head, maquet dispatched the informative technical notice n.I.T.210 reminding the importance of the tightening control after installation or maintenance.We believe that all remaining devices are performing correctly in the market.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.The correction of b5 describe event or problem, d4 catalog # and h4 device manufacture date fields deems required.This is based on the additional information that has been received.Previous b5 describe event or problem: on 9th february, 2022 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated that the dome detached from the spring arm during cleaning.Due to the issue the cleaner has a problem with her wrist.We decided to report the issue based on potential as any parts falling on a person could lead to serious injury.Corrected b5 describe event or problem: on 9th february, 2022 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated that the dome detached from the spring arm during cleaning.Due to the issue the cleaner complained of a bad wrist and went to the emergency room to be examined, according to the analysis, nothing was broken.We decided to report the issue based on potential as any parts falling on a person could lead to serious injury.Previous d4 catalog #: ardpwt229030a.Corrected d4 catalog #: ard569202965.Previous h4 device manufacture date: 11/15/2019.Corrected h4 device manufacture date: 05/04/2020.

Event Description

On 9th february, 2022 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated that the dome detached from the spring arm during cleaning.Due to the issue the cleaner complained of a bad wrist and went to the emergency room to be examined, according to the analysis, nothing was broken.We decided to report the issue based on potential as any parts falling on a person could lead to serious injury.

• Brand Name: POWERLED II
• 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: 13521321
• MDR Text Key: 285524706
• Report Number: 9710055-2022-00062
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDPWT229030A
• Device Catalogue Number: ARD569202965
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 02/24/2022
• Supplement Dates FDA Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other