MAUDE Adverse Event Report: VYAIRE MEDICAL BOXED PATIENT CIRCUIT ASSY, 3100A, 850L; VENTILATOR, HIGH FREQUENCY

Model Number BOXED PATIENT CIRCUIT ASSY, 3100A, 850L

Device Problem Disconnection (1171)

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

Event Date 10/03/2022

Event Type  Injury  

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.

Event Description

It was reported to vyaire medical that the tubing from boxed patient circuit assy, 3100a, 850l disconnected from the humidifier while in use on a patient using a sensormedic 3100a oscillator ventilator.The circuit came apart at the joint, causing it to disconnect.The patient was not harmed as they were being disconnected by the staff for suctioning and the fault happened while trying to reconnect on both occasions.It was spotted quickly and resolved by reconnecting the hose to the plastic connector.

• Brand Name: BOXED PATIENT CIRCUIT ASSY, 3100A, 850L
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15710913
• MDR Text Key: 302829390
• Report Number: 8030673-2022-00278
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2022

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
• Device Operator: Health Professional
• Device Model Number: BOXED PATIENT CIRCUIT ASSY, 3100A, 850L
• Device Catalogue Number: 29028-004
• Device Lot Number: 0004189369
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention