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

Model Number ARD567237998

Device Problems Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

E1b event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.

Event Description

On 6th march, 2024 getinge became aware of an issue with one of surgical lights - prismalix.It was stated the surgical light detached and was hanging from the ceiling.Issue occurred during use.A transplant case was apparently ongoing when the light detached and continued on for several more hours after the light was removed.No patient injury/harm reported.Additionally, based on photographic evidence the designated complaint unit employee found that paint was peeling from the spring arm and fork, also the dust cover from spring arm was missing.We decided to report the issue in abundance of caution as any device detachment may lead to serious injury and as any parts or particles falling off into sterile field or during procedure may cause contamination.

• Brand Name: PRISMALIX
• 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: 18940639
• MDR Text Key: 338130499
• Report Number: 9710055-2024-00219
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/20/2024

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: ARD567237998
• Device Catalogue Number: ARD567237998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1