MAUDE Adverse Event Report: MAQUET SAS PENDANTS; TUBING, PRESSURE AND ACCESSORIES

Model Number ARD517002958

Device Problem Peeled/Delaminated (1454)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

Event site name: (b)(6) center, event site telephone: (b)(6), contact person name: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 6th february, 2024 getinge became aware of an issue with one of surgical equipment - pendant.The received customer allegation regarded a non-reportable issue.Designated complaint unit employee confirmed based on photographic evidence that labels were chipping.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

• Brand Name: PENDANTS
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• 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: 18709926
• MDR Text Key: 335407733
• Report Number: 9710055-2024-00148
• Device Sequence Number: 1
• Product Code: BYX
• 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: Other
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD517002958
• Device Catalogue Number: ARD517002958
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/20/2007
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1