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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE

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FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE Back to Search Results
Model Number RT266
Device Problem Moisture or Humidity Problem (2986)
Patient Problem Aspiration/Inhalation (1725)
Event Date 09/11/2014
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Since the reported incident an fph representative has visited the hospital and is working with the hospital staff to determine the root cause and to develop an action plan. Our investigation is currently in progress and we will provide a follow up report upon completion of our investigation.
 
Manufacturer Narrative
(b)(4). Method: the complaint device was not available for evaluation. Therefore, our investigation is based on the information provided by the hospital, previous similar investigations and our knowledge of the product. Results: the hospital reported that there was rainout in the swivel adaptor of an rt266 infant evaqua2 breathing circuit. Conclusion: without the return of the complaint device we are unable to determine what may have caused the reported rainout. If the complaint device was returned it would have been performance tested to check for any excessive condensation. Furthermore, the inspiratory and expiratory heater wires would have been resistance tested with a calibrated multimeter. Condensate in the humidification system, is an expected side effect of heated pass-over humidification systems in many conditions, and may vary between light misting to water droplets that form on the wall of cool breathing circuit tubing. The amount of condensate in the ventilation system is influenced by a number of multiple setup and environmental factors. The user instructions that are accompanied with the rt266 state: "set appropriate ventilator alarms. " "check breathing circuit for condensation every 6 hours and drain if required. " since the reported incident a fisher & paykel healthcare representative has visited the hospital to discuss the correct set up and use of the rt266 infant evaqua2 breathing circuit. The fph rep is working with the hospital to address the reported condensation issue.
 
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare representative that the rt266 infant dual heated evaqua2 breathing circuit has rainout in the swivel wye. They further reported that a nurse moved the patient and some of the water in the swivel wye went down the patient's trache and caused the patient to aspirate water.
 
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare representative that the rt266 infant dual heated evaqua2 breathing circuit has rainout in the swivel wye. They further reported that a nurse moved the patient and some of the water in the swivel wye went down the patient's trache and caused the patient to aspirate water.
 
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Brand NameINFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Type of DeviceBZE
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ 2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ 2013
Manufacturer Contact
raymond yan
15365 barranca parkway
irvine, CA 92618-2216
9494534000
MDR Report Key4157796
MDR Text Key12320688
Report Number9611451-2014-00806
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103767
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Respiratory Therapist
Type of Report Initial,Followup
Report Date 09/11/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRT266
Device Catalogue NumberRT266
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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