MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH PRODUCT VYNTUS BODY

Catalog Number	VYNB
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer complained that the us sensor detaches easily.No patient injuries happened.

• Brand Name: PRODUCT VYNTUS BODY
• Common Device Name: 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
• Report Number: 9615102-2023-00141
• Device Sequence Number: 6101206
• Product Code: JEH
• UDI-Device Identifier: 04250892904672
• UDI-Public: (01)04250892904672(11)181101
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown