MAUDE Adverse Event Report: VYAIRE MEDICAL VMAX ENCORE 22; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number OBS,VMAX ENCORE 22

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2023

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification:(b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.

Event Description

It was reported to vyaire medical that the ambient temperature of obs, vmax encore 22 exceeds threshold warning.It was found that the temperature of the module (currently) is 37 c.There is no patient involved in this case.

• Brand Name: VMAX ENCORE 22
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd,; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 17153334
• MDR Text Key: 317827428
• Report Number: 2021710-2023-17844
• Device Sequence Number: 1
• Product Code: BTY
• UDI-Device Identifier: 10846446021394
• UDI-Public: (01)10846446021394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2023

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: OBS,VMAX ENCORE 22
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: YES
• Patient Sequence Number: 1