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

Model Number ARD567225241C

Device Problem Device Tipped Over (2589)

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

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 27th february 2023 getinge became aware of an issue with one of surgical lights - mobile version of prismalix.It was stated the device wasn't working.Then the additional information was provided by getinge technician, the customer had toppled the device and it landed on its side.Then they checked the device and found the power connector had fallen apart in headlight, then it was reconnected.Our technician checked the device and no problems were found.There was no injury reported, however, we decided to report the issue in abundance of caution as the fall of the device could lead to serious injury.

Manufacturer Narrative

The correction of d4 catalog # deems required.This is based on the internal evaluation.Previous d4 catalog # ard567225241c, corrected d4 catalog # ard567236993.Getinge became aware of an issue with one of surgical lights - mobile version of prismalix.It was stated the device was not working.Then the additional information was provided by getinge technician, the customer had toppled the device and it landed on its side.Then they checked the device and found the power connector had fallen apart in headlight, then it was reconnected.Our technician checked the device and no problems were found.There was no injury reported, however, we decided to report the issue in abundance of caution as the fall of the device could lead to serious injury.According to the information provided by getinge technician, the affected device was released for use after being checked and tested.Based on the information collected, it was established that when the event occurred, the light did not meet its specification, since the breakage of the light occurred and this could be considered as technical deficiency.That however was an effect of the situation where the user toppled the device and in this way the device contributed to the event.The provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.A root cause analysis was performed by subject matter experts at manufacturing site.As it was stated, the breakage is the result of falling of the mobile light.Based on information provided by the getinge technician, ¿customer had toppled light and had landed on its site¿.Therefore, the cause of the breakage is related to misuse.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 could have been avoided.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).

• Brand Name: PRISMALIX
• 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: 16528099
• MDR Text Key: 311153779
• Report Number: 9710055-2023-00203
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD567225241C
• Device Catalogue Number: ARD567236993
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2002
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1