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U.S. Department of Health and Human Services

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

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FISHER & PAYKEL HEALTHCARE LIMITED ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE Back to Search Results
Model Number RT380
Device Problems Fracture (1260); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The expiratory limb of the complaint rt380 adult dual heated evaqua2 breathing circuit was received at fisher & paykel healthcare in (b)(4) and was visually inspected and pressure tested. Visual inspection confirmed that the expiratory limb collar was cracked and the results of the pressure test were outside of specification. The healthcare facility confirmed that the device had passed initial leak testing. We were unable to determine conclusively what had caused the collar to crack; however, based on our previous investigations it is possible that the crack is due to being in contact with a chemical solution, resulting in environmental stress cracking. All rt380 circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected. The user instructions that accompany the rt380 adult dual heated evaqua2 breathing circuit state: "do not soak, wash, sterilize or reuse this product. Avoid contact with chemicals, cleaning agents or hand sanitizers. " "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient. " "set appropriate ventilator alarms. ".
 
Event Description
Our distributor in (b)(6) reported on behalf of a healthcare facility that they found a crack on the collar of the expiratory limb of an rt380 adult dual heated evaqua2 breathing circuit after one week of use. There was no reported patient consequence.
 
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Brand NameADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Type of DeviceBZE
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland, 2013
NZ 2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland, 2013
NZ 2013
Manufacturer Contact
faranak gomarooni
173 technology dr.
suite 100
irvine, CA 92618
9494534000
MDR Report Key8118432
MDR Text Key129485294
Report Number9611451-2018-01018
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K122432
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 10/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRT380
Device Catalogue NumberRT380
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2018
Was Device Evaluated by Manufacturer? Yes
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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