MAUDE Adverse Event Report: MAQUET SAS BLUELINE; LIGHT, SURGICAL, FLOOR STANDING

Catalog Number ARD569098999

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 13th may, 2022 getinge became aware of an issue with one of our surgical lights ¿ blueline.The acrylic cover was missing.No injury was reported due to mentioned issue, however, we decided to report this case in abundance of caution as any parts or particles falling down might cause contamination or led to serious injury.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights ¿ blueline.The acrylic cover was missing.No injury was reported due to mentioned issue, however, we decided to report this case in abundance of caution as any parts or particles falling down might cause contamination or led to serious injury.The defective part was replaced and the equipment was released for use.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event due to missing cover.None of information available to date suggest that at the time when the event occurred the device was being used for the patient treatment.As manufacturer¿s subject matter experts established it is impossible to determinate the exact cause of missing of the acrylic cover.The probable root cause is damaged by misuse as described in the complaint.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 ot (b)(4).

• Brand Name: BLUELINE
• Type of Device: LIGHT, SURGICAL, FLOOR STANDING
• 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: 14613824
• MDR Text Key: 293715268
• Report Number: 9710055-2022-00183
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ARD569098999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1