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U.S. Department of Health and Human Services

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

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FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE Back to Search Results
Model Number RT380
Device Problem Moisture or Humidity Problem (2986)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Since the reported incident an fph representative has been in contact with the hospital. Furhtermore, the complaint devices are currently en route to fisher & paykel healthcare in (b)(4) for evaluation. We will provide a follow up report upon completion of our investigation.
 
Manufacturer Narrative
(b)(4). Returned devices: 1 x rt380 lot 1309010301 date of manufacture: 1 september 2013, 1 x rt380 lot 1305220301 date of manufacture: 22 may 2013. Method: two rt380 adult dual heated evaqua2 breathing circuits from the same lots as the complaint devices were returned to fph in new zealand for investigation. Both circuits were unopened and were returned in sealed bags. The inspiratory and expiratory heater wires for both circuits were resistance tested using a calibrated multimeter. Results: resistance test revealed that the inspiratory and expiratory heater wires on both of the returned circuits were within specification. A lot check revealed no other complaints of this nature for lots 130901 & 130522. Conclusion: we are unable to determine what may have caused the reported incident. Since the reported event, an fph representative has been working with the hospital staff to address the reported condensation issue. After the fph rep visited the hospital reported that they have not had any further issues regarding condensation. 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 accompany the rt380 state the following: -"set appropriate ventilator alarms". -"check breathing circuits for condensation every 6 hours and drain if required. ".
 
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) representative that they noticed condensation in the expiratory limb of an rt380 adult dual heated evaqua2 breathing circuit. This was found after 48 hours of use. Upon changing the breathing circuit to another rt380 they continued to experience more than usual condensation. The hospital also reported that the patient experienced arrhythmias and hypertension.
 
Event Description
A hospital in (b)(4) reported to a fisher & paykel healthcare (fph) representative that they noticed condensation in the expiratory limb of an rt380 adult dual heated evaqua2 breathing circuit. This was found after 48 hours of use. Upon changing the breathing circuit to another rt380 they continued to experience more than usual condensation. The hospital also reported that the patient experienced arrhythmias and hypertension.
 
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Brand NameADULT 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 Key4137256
MDR Text Key12421123
Report Number9611451-2014-00793
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K122432
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/03/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRT380
Device Catalogue NumberRT380
Device Lot Number1305220301
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received09/03/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2013
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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