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

Model Number ARD568320905

Device Problem 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 issue with powerled surgical light.As it was stated, the covers were missing on the device.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with powerled surgical light.As it was stated, the covers were missing on the device.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off may cause contamination.During the investigation, it was concluded that the device involved did not meet the manufacturer¿s specification and it contributed to the event.We received information that the device 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 the investigated issue has never led to serious injury or worse.Comparing the number of complaints registered to number of sold devices, complaint ratio is low.Per the investigation of the subject matter experts at the manufacturing site, the incident is due to an inappropriate use.The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.Additionally, the users are requested to pay attention to cracks in plastic parts.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manfuacturer'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: 13050781
• MDR Text Key: 282557576
• Report Number: 9710055-2021-00378
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

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: ARD568320905
• Device Catalogue Number: ARD568320905
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 12/28/2021
• Supplement Dates FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1