MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP; LAMP, SURGICAL

Model Number ARD568603902

Device Problem Peeled/Delaminated (1454)

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 24th of august 2021 getinge became aware of an issue with volista standop device.The layer of keypad was peeled.There was no injury reported however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with volista standop device.The keypad front panel detached and fell.There was no injury reported however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Based on communication between getinge technician and subject matter expert at manufacturing site it can be assumed that after the faulty keypad was returned for evaluation to maquet sas the technician installed new keypad on the surgical light.It was established that when the event occurred, the surgical light did not meet its specification due to detachment of keypad¿s front panel, which contributed to the event.Provided information indicate that upon the event occurrence the device was not being used for patient treatment.Review of received customer product complaints related to investigated issue, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the failure ratio of the detachment of the keypad¿s front panel occurrence is very low.According to the subject matter expert, it was impossible to confirm and duplicate problem described by the getinge technician because claimed keypad had been received with the front panel in place and firmly glued by the customer.Although the front panel was glued, maquet sas specialists tried to unstick and detach this panel from the keypad.As stated, it was only possible with great effort.To sum up, during the tests performed by the subject matter expert, the problem was not reproduced and the root cause could not be established.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 reference number (b)(4).

• Brand Name: VOLISTA STANDOP
• Type of Device: LAMP, SURGICAL
• 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: 12370100
• MDR Text Key: 268221057
• Report Number: 9710055-2021-00292
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: LO
• 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,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568603902
• Device Catalogue Number: ARD568851961
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1