MAUDE Adverse Event Report: MAQUET SAS BLUE 80-30; LIGHT, SURGICAL, FLOOR STANDING

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 26th july, 2021 getinge became aware of an issue with one of our surgical lights ¿ blue 80-30.The cover and screws were missing.No injury was reported due to mentioned issues, however, we decided to report this case in abundance of caution as any parts falling down might cause contamination or led to serious injury.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights ¿ blue 80-30.The cover and screws were missing.No injury was reported due to mentioned issues, however, we decided to report this case in abundance of caution as any parts falling down might cause contamination or led to serious injury.It was established that when the event occurred, the device did not meet its specification, due to cover and screw were missing on the device and it contributed to event.It was not established if in the time when the event occurred the device was or was not being used for the patient treatment.During the investigation, it was found that the reported scenario has never led, to date, to serious injury or worse.Manufacturer did not receive enough information to conduct the technical investigation.It is not possible to determine the part involved and the root cause.In case of new relevant information, the case will be reconsidered.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: BLUE 80-30
• 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: 12251281
• MDR Text Key: 264275730
• Report Number: 9710055-2021-00252
• 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: 11/09/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 07/30/2021
• Supplement Dates Manufacturer Received: 10/27/2021
• Supplement Dates FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose