MAUDE Adverse Event Report: MAQUET SAS POWERLED 500; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568425010A

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

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

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The initial reporter was getinge technician.Event site name: (b)(6) hospital.H3 other text : device not returned to manufacturer.

Event Description

On (b)(6), 2023 getinge became aware of an issue with one of surgical lights - powerled 500.It was stated the dust covers had came off the spring arm.It has been brought to getinge technician attention that night shift hospital engineers have been putting them back in themselves prior to the incident.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.

Manufacturer Narrative

Initially provided information was pointing to dust cover detachment.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Based on additional clarifications we were able to determine that dust covers did not detach and were simply bent.Therefore, the initially considered risk was not present on this device.Therefore, the scenario described in the record is considered as non-reportable.It is not likely that the event could lead to the serious injury or death when the malfunction reoccurs.The correction of b5 describe event or problem, d4 version or model #, d4 catalog # and d4 serial #, h6 medical device ¿ problem code fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 15th september, 2023 getinge became aware of an issue with one of surgical lights - powerled 500.It was stated the dust covers had came off the spring arm.It has been brought to getinge technician attention that night shift hospital engineers have been putting them back in themselves prior to the incident.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event or problem: on 15th september, 2023 getinge became aware of an issue with one of surgical lights - powerled 500.As it was initially stated, the dust covers had came off the spring arm.It has been brought to getinge technician attention that night shift hospital engineers have been putting them back in themselves prior to the incident.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Upon further clarifications it has been confirmed that the dust covers on this device were only bent and did not detach from the device.The detachment of dust cover occurred on different device and it covered under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00708).Based on the clarifications it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of risk of falling parts, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.It is not likely that the issue could lead to the serious injury or death when the malfunction reoccurs.Previous d4 version or model # ard568422010c.Corrected d4 version or model # ard568425010a.Previous d4 catalog # ard568422010c.Corrected d4 catalog # ard568351938/ard568350933.Previous d4 serial # (b)(6).Previous h6 medical device ¿ problem code: mechanical problem|detachment of device or device component||2907.Corrected h6 medical device ¿ problem code: material integrity problem|material deformation|material twisted/bent|2981.

Event Description

On 15th september, 2023 getinge became aware of an issue with one of surgical lights - powerled 500.As it was initially stated, the dust covers had came off the spring arm.It has been brought to getinge technician attention that night shift hospital engineers have been putting them back in themselves prior to the incident.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Upon further clarifications it has been confirmed that the dust covers on this device were only bent and did not detach from the device.The detachment of dust cover occurred on different device and it covered under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00708).Based on the clarifications it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of risk of falling parts, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.It is not likely that the issue could lead to the serious injury or death when the malfunction reoccurs.

• Brand Name: POWERLED 500
• 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: 17779105
• MDR Text Key: 323796222
• Report Number: 9710055-2023-00713
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 03700712402563
• UDI-Public: (01)03700712402563
• 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
• Report Date: 09/20/2023

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: ARD568425010A
• Device Catalogue Number: ARD568351938/ARD568350933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1