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

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 308150479
• Report Number: 3004553423-2023-01748
• Device Sequence Number: 1
• Product Code: BZO
• UDI-Device Identifier: 07640149388985
• UDI-Public: (01)07640149388985(11)20220511
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male