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

Model Number	IFLOW 200S PLUS FLOW SENSOR, SINGLE USE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
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 the bellavista1000 had a cracked flow sensor during patient use.Furthermore, the patient was intubated and sedated on an acvc ventilator.The iflow 200s adult proximal flow sensor snapped while the patient was being turned for cleaning by nursing staff, resulting in a disconnect between the patient's et tube and the ventilator.The patient's spo2 began to fall, and was not taking spontaneous breaths due to sedation; the patient needed to be bag-mask-ventilated for 3-4 minutes before the tubing was replaced by rt.
Additional Manufacturer Narrative
Results of investigation: vyaire medical was able to confirm the issue.The vyaire failure analysis laboratory received the suspect component and performed a failure investigation.Visual inspection of the flow sensor revealed that it had separated at the center seam.It has been determined that the flow sensor was not sufficiently ultrasonically welded during manufacturing.The root cause of failure was determined to be breakage caused by insufficient ultrasonic weld during manufacturing.Despite a thorough investigation of several returned defective parts from the field in i-ch-20-032, the exact root cause could not be determined.There were no indications of an issue with the ultrasonic welding joint, a batch problem, or anything else.Based on simulations and break tests conducted during the investigation, the most likely root cause is improper / rough handling.The decision was made not to pursue further investigation because the failure rate is extremely low.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)
• Manufacturer (Section D): IMTMEDICAL PTE. LTD.; 10 jalan kilang sime darby; 15941 ; SN 15941
• Manufacturer (Section G): TECHNOCOM SYSTEMS SDN BHD; plo 1 jalan firma 1; kawasan perindustrian tebrau 1; johor bahru ; MY
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16191539
• Report Number: 3013407532-2023-00003
• Device Sequence Number: 5970851
• Product Code: BZO
• UDI-Device Identifier: 07640149388985
• UDI-Public: (01)07640149388985(10)3922A(11)20220511
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

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 200S PLUS FLOW SENSOR, SINGLE USE
• Device Catalogue Number: 301.328.020
• Device Lot Number: 3922A
• 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: 12/27/2022
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• 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