MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, INC. EVAQUA 2; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER)

Model Number EVAQUA 2

Device Problem Moisture Damage (1405)

Patient Problem No Information (3190)

Event Date 08/17/2015

Event Type  malfunction  

Event Description

During the implementation of a new circuit for humidification/heating by fisher paykel - extreme moisture is present in the circuit as well as within the filter on both the patient and the ventilator side.Manufacturer response for heater humidifier, evaqua 2 (per site reporter): mfg has not been responsive.

• Brand Name: EVAQUA 2
• Type of Device: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.; 15365 barranca parkway; irvine CA 92618
• MDR Report Key: 5067044
• MDR Text Key: 25349581
• Report Number: 5067044
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Report Date: 08/18/2015

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?: No
• Device Operator: No Information
• Device Model Number: EVAQUA 2
• Device Catalogue Number: RT265
• Device Lot Number: 15050
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: YES - DRAGER V500 VENTILATOR