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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 Crack (1135); Fracture (1260); Leak/Splash (1354); Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The complaint rt380 breathing circuit is currently en route to fisher & paykel healthcare (b)(4) for evaluation. We are in process to determine if f&p's product caused or contributed to the reported event. We will provide a follow up report upon completion of our investigation.
 
Event Description
A healthcare facility in (b)(6) reported via a distributor to an fisher & paykel healthcare (f&p) field representative that a leak alarm was generated from a servo ventilator after 2 weeks of use. A crack on the collar of the expiratory limb of the rt380 adult dual heated evaqua2 breathing circuit was identified. 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 Key8512693
MDR Text Key142231285
Report Number9611451-2019-00369
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,Followup
Report Date 03/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRT380
Device Catalogue NumberRT380
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2019
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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