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

Model Number	VYNONE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Abrasion (1689); Bruise/Contusion (1754)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9615102-2024-00146
• Device Sequence Number: 6035668
• Product Code: BZC
• UDI-Device Identifier: 04250892904696
• UDI-Public: (01)04250892904696
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: VYNONE
• Device Catalogue Number: V-178601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown