MAUDE Adverse Event Report: IFLOW; SET,TUBING AND SUPPORT, VENTILATOR (W/HARNESS)

Model Number	IFLOW 200 S PROXIMAL FLOW SENSOR (ADULT/PEDIATRIC, SINGLE-PATIENT, 1 PACK=10 PC)
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).At this time, the suspect component/device has not been returned for evaluation.No root cause has not been determined yet.This complaint is link to manufacturer's reference number: (b)(4).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 to vyaire medical that the green component of the iflow 200 s was disconnected from main part of the flow sensor happened prior connecting the patient to ventilator.The customer confirmed that there was a delay in connecting while waiting for another flow sensor yet no patient harm was reported.Three (3) out of 10 sensors were defective which confirmed happened into three(3) separate patients.
Additional Manufacturer Narrative
Results of investigation: the suspect component was not returned for investigation.Vyaire medical determined root cause as due to a defective iflow 200 s single-use proximal flow sensor.Most likely the rough handling, the exact root cause is unknown.Initiated iflow sensor replacement and the issue resolved.

• Brand Name: IFLOW
• Common Device Name: SET,TUBING AND SUPPORT, VENTILATOR (W/HARNESS)
• MDR Report Key: 12199969
• Report Number: 3013407532-2021-00012
• Device Sequence Number: 14302182
• Product Code: BZO
• UDI-Device Identifier: 07640149381344
• UDI-Public: (01)07640149381344
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: IFLOW 200 S PROXIMAL FLOW SENSOR (ADULT/PEDIATRIC, SINGLE-PATIENT, 1 PACK=10 PC)
• Device Catalogue Number: 301.328.010
• Device Lot Number: 2520
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 10/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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