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

Model Number HM55002086

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 one of our surgical lights ¿ blue 80.As it was stated, the on/off switch was mechanically damaged, photographic evidence is showing lack of this switch on the headlight.No injury was reported due to mentioned issue, however, we decided to report this case in abundance of caution as any parts falling down might cause contamination or led to serious injury.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

On 29th july, 2021 getinge became aware of an issue with one of our surgical lights ¿ blue 80.As it was stated, the on/off switch was mechanically damaged, photographic evidence is showing this switch is no longer present on the headlight.No injury was reported due to the mentioned issue, however, we decided to report this case in abundance of caution as any parts falling down might cause contamination or lead to serious injury.According to the service technician, the defective parts were replaced and the device was returned to service.It was established that when the event occurred, the surgical light did not meet its specification, since detachment of switch could be considered as technical deficiency, and in this way device contributed to event.It is unknown if the device was being used for patient treatment at the time when the event occurred.Based on the performed trend review we conclude that the issue under this investigation is first event connected to missing on/off switch on ¿blue¿ series devices and the issue has never led to serious injury or worse, to our knowledge.The information of this complaint was shared with product experts at the manufacturer ¿ who felt they did not receive enough information to conduct the technical investigation.Nevertheless, it can be suggested the probable causes of the deterioration of the button may be due to collision or excessive use /application effort.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.

• Brand Name: BLUE 80
• 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: 12265593
• MDR Text Key: 264737996
• Report Number: 9710055-2021-00255
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HM55002086
• Device Catalogue Number: HM55002086
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1