MAUDE Adverse Event Report: MAQUET SAS MODULE MOBILI 800 MODUTEC, 1 DRAWER 400X500 MODUTEC; TUBING, PRESSURE AND ACCESSORIES

Model Number ARD517001956/ARD517001785

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Event Description

On 9th november, 2023 getinge became aware of an issue with one of surgical equipment - configuration of module mobili 800 modutec and 1 drawer 400x500 modutec.It was found during annual maintenance the paint has worn off in the corner of the drawer tableau.The issue was confirmed by photographic evidence.It was established by technician the issue occurred probably due to bumping and cleaning.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.H3 other text : device not returned to manufacturer.

• Brand Name: MODULE MOBILI 800 MODUTEC, 1 DRAWER 400X500 MODUTEC
• 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: 18197214
• MDR Text Key: 328922033
• Report Number: 9710055-2023-00904
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD517001956/ARD517001785
• Device Catalogue Number: ARD517001956/ARD517001785
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2008
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1