MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH PRODUCT VYNTUS BODY

Catalog Number VYNB

Device Problem Mechanical Problem (1384)

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

Event Date 05/11/2023

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2023 during a complaint search it became evident, that this complaint is a similar complaint to the reportable complaint (b)(4).The reporting decision was updated accordingly.The customer called and complained that the us sensor easily becomes loose and could fall down in case a patient touches it unintentional.During remote troubleshooting no final cause could be identified.The sensor was not sent back for investigation.The us sensor was replaced during a standard maintenance at customers site.The capa investigation identified the following root cause: misuse of the uss as a ¿handle¿ to change the support arm position instead of using the proper handle of the vyntus body support arm or the support arm itself.This misuse loosens the mechanical connection between the uss and the fpv so it becomes insufficient to hold the uss in place.

Event Description

The customer complained that the us sensor detaches easily.No patient injuries happened.

• Brand Name: PRODUCT VYNTUS BODY
• Type of Device: VYNTUS BODY
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer Contact: maren wiese ; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• MDR Report Key: 17827558
• MDR Text Key: 324395678
• Report Number: 9615102-2023-00141
• Device Sequence Number: 1
• Product Code: JEH
• UDI-Device Identifier: 04250892904672
• UDI-Public: (01)04250892904672(11)181101
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2023

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 Catalogue Number: VYNB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1