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	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was sent to us for evaluation but we have not received it yet.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 bellavista - iflow 200s sensor came apart while on a patient.Furthermore, the customer confirmed that the patient was removed from the ventilator due to problem but no patient harm associated with the event.
Additional Manufacturer Narrative
Results of investigation: the suspect device was not returned for investigation.Vyaire medical was unable to determine the exact root cause but most likely it is due to an improper/ rough handling based on simulations and break tests performed.
Additional Manufacturer Narrative
The suspect device was sent to us for evaluation but we have not received it yet.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 bellavista - iflow 200s sensor came apart while on a patient.Furthermore, the customer confirmed that the patient was removed from the ventilator due to problem but no patient harm associated with the event.

• Brand Name: IFLOW
• Common Device Name: SET,TUBING AND SUPPORT, VENTILATOR (W/HARNESS)
• Manufacturer (Section D): IMTMEDICAL PTE. LTD.; 510 technology dr10 jalan kila; singapore
• 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: 12836993
• Report Number: 3004553423-2021-01268
• Device Sequence Number: 4351766
• Product Code: BZO
• UDI-Device Identifier: 07640149380767
• UDI-Public: (01)07640149380767
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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 ADULT/PEDIATRIC PROXIMAL FLOW SENSOR
• Device Catalogue Number: 301.328.020
• Device Lot Number: 4620
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 111 KG