MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. (CAREFUSION GERMANY 234 GMBH) VYNTUS WALK 6MWT TABLET W. APP; Oximeter

Model Number	VYNTUS WALK 6MWT TABLET W. APP
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During investigation a new potential risk has been identified.Therefore the become aware date changed to the date of the clinical risk assessment request (19-mar-2024).The decision trees have been updated accordingly.The lenovo tablet is a third party it equipment which is not further investigated by vyaire.Lenovo has the appropriate declaration of conformity and adheres to all applicable safety standards.The usage of tablets which fulfil applicable safety standards is state of the art.The most likely root-cause is a battery failure of the lenovo tablet.The broken tablet was replaced on the (b)(6) 2024.The risk evaluation results in a risk acceptance level of a medium acceptable health risk.
Event or Problem Description
The customer complained that the battery of the lenovo tablet is swollen.There was no patient involvement.

• Brand Name: VYNTUS WALK 6MWT TABLET W. APP
• Common Device Name: Oximeter
• Manufacturer (Section D): VYAIRE MEDICAL, INC. (CAREFUSION GERMANY 234 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 ; 2402760001
• MDR Report Key: 19123956
• Report Number: 3010838917-2024-00114
• Device Sequence Number: 12819468
• Product Code: DQA
• UDI-Device Identifier: 54250892904899
• UDI-Public: (01)54250892904899
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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: VYNTUS WALK 6MWT TABLET W. APP
• Device Catalogue Number: V-178501
• 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: 03/19/2024
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown