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	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported that they are not sure if they will return the defective unit/part for evaluation.They do not have the device, and not sure if it was retained.Therefore, no root cause could be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Device not returned.
Event or Problem Description
It was reported to vyaire medical problem with iflow 200s plus flow sensor where patient was being turned in the process of personal care, the device snapped and caused the patient's et (endotracheal) tube to become disconnected from the ventilator.Furthermore, there was no harm due to the swift reaction of staff to bag the patient until device could be replaced.

• Brand Name: IFLOW
• Common Device Name: SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
• Manufacturer (Section D): IMTMEDICAL PTE. LTD.; 10 jalan kilang bt; merah enterprise centre #07-01; singapore central 15941 0; SN 159410
• 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: 16244972
• Report Number: 3004553423-2023-01748
• Device Sequence Number: 12363798
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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 200 S ADULT/PEDIATRIC PROXIMAL FLOW SENSOR
• Device Catalogue Number: 301.328.020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 50 YR
• Patient Sex: Male