MAUDE Adverse Event Report: VYAIRE MEDICAL REVEL, ENGLISH SERVICE REPAIR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	REVEL, ENGLISH SERVICE REPAIR
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that the unit running on a patient during a transport.This unit was running on the patient on volume ac, vt 450, rate 18.It was noticed the respiratory rate on their external etco2 monitor was reading 12-14 consistently.They are aware this is an external monitor, not the vent.The vent was reading 18 as well.They took the unit aside after the transport and had the rate still set to 18 and timed the breaths with a watch and got 12 breaths per minute.No patient harm was reported.
Additional 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.

• Brand Name: REVEL, ENGLISH SERVICE REPAIR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 19282392
• Report Number: 2021710-2024-19080
• Device Sequence Number: 6358509
• Product Code: CBK
• UDI-Device Identifier: 10190752157071
• UDI-Public: (01)10190752157071
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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: REVEL, ENGLISH SERVICE REPAIR
• Device Catalogue Number: 19260-001-99
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown