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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 Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2016
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 rt266 infant dual-heated evaqua2 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 via a fisher & paykel healthcare field representative that an rt266 infant dual-heated evaqua2 breathing circuit failed the ventilator leak test.The incident occurred before patient use.No patient consequence was reported.
 
Manufacturer Narrative
(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel heatlhcare in (b)(4) where it was visually inspected and pressure tested for leak.Results: visual inspection revealed no damage to the returned breathing circuit.Pressure test revealed that the breathing circuit was within specification.Conclusion: we were unable to determine what may have caused the leak reported by the customer as no fault was found with the returned complaint device.A leak in the breathing circuit is usually detected by an alarm on the ventilator.All rt266 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt266 infant dual heated evaqua2 breathing circuit state the following: check all connections are tight before use.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Set appropriate ventilator alarms.Do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.
 
Event Description
A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that an rt266 infant dual-heated evaqua2 breathing circuit failed the ventilator leak test.The incident occurred before patient use.No patient consequence was reported.
 
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Brand Name
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Type of Device
BZE
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 Key5684164
MDR Text Key47197163
Report Number9611451-2016-00235
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103767
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT266
Device Catalogue NumberRT266
Device Lot Number160128
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received04/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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