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

Model Number	19260-001-99
Medical Device Problem Code	Intermittent Infusion (2341)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported to vyaire medical that the ventilator had a damaged power pigtail and was giving the patient intermittent bipap breaths "vent was on the patient.It seemed to be working fine, then just stopped delivering a breath, repeatedly while we were troubleshooting.The patient was signaling that she couldn't get a breath, we tried troubleshooting it and on the third time we removed it and put her on flow driven cpap." no patient harm reported.
Additional Manufacturer Narrative
H3: finding/root cause: unable to duplicate the reported complaint.Uut was functioning with no faults.Disposition: revel, english service repair p/n:19260-001-99 s/n:(b)(6) will be moved to factory service.Replaced hybrid pcba, o2 module, exhalation module, pressure module, flow sensor as a precautionary measure and pigtail.Replace materials as required, rework to configuration, recalibrate, and retest per specifications & standards.
Event or Problem Description
Additional information received indicates that the ventilator was returned for further investigation.Fa lab was unable to duplicate the reported complaint.Uut was functioning with no faults.

• Brand Name: REVEL
• 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 ; 2402760001
• MDR Report Key: 19583667
• Report Number: 3013421741-2024-00211
• Device Sequence Number: 7279874
• Product Code: CBK
• UDI-Device Identifier: 10190752157071
• UDI-Public: (01)10190752157071(11)20131031
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: 19260-001-99
• Device Catalogue Number: 19260-001-99
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2013
• 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