MAUDE Adverse Event Report: VYAIRE MEDICAL, INC 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number FISHER & PAYKEL MR730 HUMIDIFIER FLEXIBLE CIRCUIT WITH LONG HEATED WIRE

Device Problems Insufficient Heating (1287); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

Vyaire medical complaint number (b)(4).At this time, vyaire medical has not received the suspect device/component from the customer for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported that the patient successfully passed testing, but the flexible heater wire failed to heat up, while in use on a patient.The patient circuit was replaced with another patient circuit and there was no patient harm/injury associated with this reported issue.

Manufacturer Narrative

At this time, vyaire medical has not received the suspect device, a 3100a (b)(4) mr730 humidifier flexible circuit with long heated wire, for evaluation.A device history record review was not possible as the customer did not report the lot number of the suspect device.No further device investigation is possible at this time.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL, INC; cerrada via de la produccion; no. 85., parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7170297
• MDR Text Key: 96582771
• Report Number: 8030673-2018-00401
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FISHER & PAYKEL MR730 HUMIDIFIER FLEXIBLE CIRCUIT WITH LONG HEATED WIRE
• Device Catalogue Number: 771375
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention