MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. (CAREFUSION GERMANY 234 GMBH) PRODUCT VYNTUS ONE; CALCULATOR, PULMONARY FUNCTION DATA

Model Number VYNONE

Device Problem Use of Device Problem (1670)

Patient Problems Abrasion (1689); Bruise/Contusion (1754)

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that the support arm was incorrect handled compared to the instructions stated in the instruction for use.The customer was informed about the correct handling and directed to the relevant page in the ifu.This incident is classified with a risk level of medium and is an acceptable patient risk.

Event Description

The customer complained that the uss module detached from the arm and as a result fell onto the patient¿s face, which was injured.The patient's lip was bruised and cut.First aid was administered by the health care provider.They used a cold tissue and compression.No further first aid was reported.

• Brand Name: PRODUCT VYNTUS ONE
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL, INC. (CAREFUSION GERMANY 234 GMBH); leibnizstrasse 7; hoechberg ; GM
• 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: 18967065
• MDR Text Key: 338436490
• Report Number: 9615102-2024-00146
• Device Sequence Number: 1
• Product Code: BZC
• UDI-Device Identifier: 04250892904696
• UDI-Public: (01)04250892904696
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/25/2024

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: VYNONE
• Device Catalogue Number: V-178601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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