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	08/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that the bellavista ventilator tube got disconnected from ett (endotracheal tube) and fell on floor.The adapter section in vent circuit was completely split.The patient was manually ventilate with bag valve mask.Patient was desaturated to 64% and quickly recovered after bag valve mask ventilaton.
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.
Additional Manufacturer Narrative
Result of investigation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.A visual inspection showed that the sensor head is broken in 2 pieces.The ultrasonic weld was inspected and found an inadequate amount of bond throughout the sensor head seam.A combination of physical damage and a not so thorough ultra-sonic weld of the sensor head seam contributed to the reported issue.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; enterprise centre#06-06; singapore, ; SN
• Manufacturer (Section G): TECHNOCOM SYSTEM SDN. BHD.; plo 1 jalan firma 1; kawasan perindustrian tebrau 1; johor bahru, 81100 ; MY 81100
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15481133
• Report Number: 3013407532-2022-00002
• Device Sequence Number: 17892301
• Product Code: BZO
• UDI-Device Identifier: 07640149388985
• UDI-Public: (01)07640149388985(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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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
• 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: 08/29/2022
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 04/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown