MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH VYNTUS SPIRO TP SPIROMETER; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Catalog Number	V-171466
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of this report, the defective laptop has not yet been returned, so no investigation could be performed.Once the laptop has been returned and investigated, a follow up report will be submitted.The broken laptop will be replaced.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 laptop is swollen and the usb ports are not working.There was no patient involvement.

• Brand Name: VYNTUS SPIRO TP SPIROMETER
• Common Device Name: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• 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 ; 2402760001
• MDR Report Key: 19678185
• Report Number: 9615102-2024-00152
• Device Sequence Number: 3239326
• Product Code: BTY
• UDI-Device Identifier: 34250892904925
• UDI-Public: (01)34250892904925
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071753
• 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: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/05/2024

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 Catalogue Number: V-171466
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown