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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 Problems Defective Component (2292); Obstruction of Flow (2423); Insufficient Information (3190)
Patient Problems Low Oxygen Saturation (2477); No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). We are currently in the process of obtaining further information from the hospital to determine if the complaint rt380 breathing circuit caused or contributed to the reported event. We are also attempting to obtain the subject complaint device for further investigation. We will provide a follow up report once we have completed our evaluation.
 
Event Description
A hospital in (b)(6) reported that an rt380 evaqua2 adult breathing circuit was used on an intubated patient. It was reported that the orotracheal intubation probe was obstructed by an alveolar capsule (mucous plug). The patient underwent bradycardia, desaturated and an emergency reintubation was required. The hospital reported that the heater wire of the rt380 circuit was allegedly faulty. The patient's condition was reported to be stable and the patient is not intubated anymore. No further patient consequence was reported.
 
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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
faranak gomarooni
173 technology drive
suite 100
irvine, CA 92618
9494534000
MDR Report Key7712691
MDR Text Key114938920
Report Number9611451-2018-00617
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K122432
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRT380
Device Catalogue NumberRT380
Device Lot Number2100410110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/23/2018 Patient Sequence Number: 1
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