MAUDE Adverse Event Report: VYAIRE MEDICAL 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number	3100 A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).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
The customer reported minimum airway pressure (paw) alarm is stuck on regardless of settings on the 3100 a ventilator.At this time, there is no information regarding patient involvement associated with the reported event.
Additional Manufacturer Narrative
Device evaluation:g3, g6, h2, h3, h6 and h10 results of investigation: vyaire medical received the device for evalution.A visual inspection of 3100 thumbwheel assembly showed the blue power wire broken away from the solder point on the printed circuit board assembly.This loss of continuity was found to be the cause of the reported calibration issues.The solder connection may have been intermittent and over time the wire completely broke away possibly through handling.It is unknown whether the breakaway point was caused during manufacturing or handling.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, CA 92618
• MDR Report Key: 14794743
• Report Number: 2021710-2022-16278
• Device Sequence Number: 17595538
• Product Code: LSZ
• UDI-Device Identifier: 10846446005394
• UDI-Public: (01)10846446005394(11)20220523
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 3100 A
• Device Catalogue Number: 768901-RNT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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