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

Model Number ARD513848999

Device Problems Corroded (1131); Peeled/Delaminated (1454)

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

Event Date 09/25/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of our device - alm.Based on photographic evidence paint and label were chipping off and rust occurred on the device.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 or serious injury.

Manufacturer Narrative

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

• Brand Name: ALM
• 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: 17841163
• MDR Text Key: 324554046
• Report Number: 9710055-2023-00730
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD513848999
• Device Catalogue Number: ARD513848999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1