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

Model Number	IFLOW 200 S ADULT/PEDIATRIC PROXIMAL FLOW SENSOR
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the bellavista-iflow sensor tubing fell on the floor with piece attached and it broke into two separate pieces cleanly.The issue occurred during patient-use and at this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.
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: exact issue is not clear as no update received from customer.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; 15941 ; SN 15941
• 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: 15419697
• Report Number: 3013407532-2022-00001
• Device Sequence Number: 6722252
• Product Code: BZO
• UDI-Device Identifier: 07640149381344
• UDI-Public: (01)07640149381344
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K163127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IFLOW 200 S ADULT/PEDIATRIC PROXIMAL FLOW SENSOR
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 35 YR
• Patient Sex: Female