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)

Device Problem Disconnection (1171)

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

Event Date 05/24/2021

Event Type  malfunction  

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 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.

Manufacturer Narrative

Device evaluation update: g3, g6, h2, h3, h6 and h10.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
• Type of Device: SET,TUBING AND SUPPORT, VENTILATOR (W/HARNESS)
• MDR Report Key: 12200014
• MDR Text Key: 262646789
• Report Number: 3013407532-2021-00013
• Device Sequence Number: 1
• Product Code: BZO
• UDI-Device Identifier: 07640149381344
• UDI-Public: (01)07640149381344
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1