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

Model Number	IFLOW 200 S PROXIMA FLOW SENSOR
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 to vyaire medical that while on a patient, the flow 200 s proxima flow sensor of bellavista splitting at the seam.Furthermore, patient was bagged with ambu bag and flow sensor was changed to another one but no patient harm reported.
Additional Manufacturer Narrative
Results of investigation: the suspect device was not returned for investigation.Despite a thorough investigation in i-ch-20-032 into multiple returned defective from the field, the specific root cause could not be determined.There were no indications of a problem with the ultrasonic welding joint, a problem or similar.The most likely root cause, based on simulations and break tests conducted during the analysis, is improper / rough handling.Because the failure rate is so low, it was decided not to examine further.This complaint will be included with on-going trending analysis.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: IFLOW
• Common Device Name: SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
• MDR Report Key: 12514498
• Report Number: 3013407532-2021-00014
• Device Sequence Number: 17389965
• Product Code: BZO
• UDI-Device Identifier: 07640149381344
• UDI-Public: (01)07640149381344
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IFLOW 200 S PROXIMA FLOW SENSOR
• Device Catalogue Number: 301.328.010
• Device Lot Number: NO INFORMATION
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention