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

Model Number	VYNTUS SPIRO LAPTOP
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The laptop should have been replaced during an on-field service visit, but the customer didn't reply despite several attempts.As the device was not returned, the complaint could not be confirmed.The customer will be informed that a swollen battery poses a safety risk to users and patients.Therefore the laptop should be returned to vyaire or if that is not possible, scrapped in accordance with hazardous materials disposal.The risk evaluation of this complaint results in a risk acceptance level of a medium acceptable health risk.
Event or Problem Description
The customer reported that the battery of the vyntus spiro laptop was swollen.There was no patient involvement.

• Brand Name: VYNTUS SPIRO LAPTOP
• 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: 20236685
• Report Number: 9615102-2024-00154
• Device Sequence Number: 8043081
• Product Code: BTY
• UDI-Device Identifier: 34250892904925
• UDI-Public: (01)34250892904925
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K071753
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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 SPIRO LAPTOP
• Device Catalogue Number: 25626-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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