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

Model Number IFLOW 200S FLOW SENSOR SINGLE USE - PACK OF 10

Device Problem Disconnection (1171)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.On 21-apr, a vyaire medical representative was informed that tga had actually completed their own investigation following the customer report direct to tga in march.No exact root cause has been concluded yet by vyaire medical.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 that the green component of the iflow 200 s proximal flow sensor were disconnected from the main part of the flow sensor and happened on two separate occasions.It was reported there was a delay in connecting patient to the ventilator.Therefore, the said flow sensor could not be used for its intended purpose.They replace the sensor with new one and connected to the ventilator, no patient harm reported.This report is regarding 2nd occasion reported.Please refer to (b)(4) for the initial reported event.

Manufacturer Narrative

Results of investigation: the suspect component was not returned for investigation.Vyaire medical was unable to establish the exact root cause, but it is most likely due to a defective iflow 200 s single-use proximal flow sensor, rough handling.As a resolution, the customer has been provided with a new sensor replacement.

• Brand Name: IFLOW
• Type of Device: SET,TUBING AND SUPPORT, VENTILATOR (W/HARNESS)
• MDR Report Key: 11803308
• MDR Text Key: 250660005
• Report Number: 3013407532-2021-00010
• Device Sequence Number: 1
• Product Code: BZO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IFLOW 200S FLOW SENSOR SINGLE USE - PACK OF 10
• Device Catalogue Number: 301.328.010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1