MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH PRODUCT VYNTUS BODY

Model Number PRODUCT VYNTUS BODY

Device Problem Mechanical Problem (1384)

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

Event Date 02/14/2023

Event Type  malfunction  

Manufacturer Narrative

On 8.Sept.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.A field service engineer went on site and checked and repaired the system using the following spare parts: 1 x v-707377, uss module with adapter, 1 x v-707389, fpv block, 1 x v-707392 assy housing clamp of fpv, after repair the device has been calibrated, tested, and works again as specified.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 called and reported that the ultrasound sensor fell down causing a defective ultrasound sensor and fpv.No patient or user was hit by the falling part.

• Brand Name: PRODUCT VYNTUS BODY
• Type of Device: VYNTUS BODY
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer Contact: maren wiese ; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• MDR Report Key: 17828296
• MDR Text Key: 324402062
• Report Number: 9615102-2023-00138
• Device Sequence Number: 1
• Product Code: JEH
• 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: Health Professional
• Reporter Occupation: Other
• Remedial Action: Repair
• 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 Operator: Health Professional
• Device Model Number: PRODUCT VYNTUS BODY
• Device Catalogue Number: VYNB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1