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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE
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FISHER & PAYKEL HEALTHCARE LIMITED INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE Back to Search Results
Model Number RT265
Device Problems Component Falling (1105); Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2014
Event Type  malfunction  
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare field representative that the patient end connector on the expiratory limb of an rt265 infant dual-heated evaqua2 breathing circuit cracked when they dropped it.The breathing circuit had been in use for approximately 3 weeks.No patient consequence was reported.
 
Manufacturer Narrative
(b)(4).The complaint device has been received at fisher & paykel healthcare in (b)(4).Our investigation is currently in progress and we will provide a follow up report upon completion of our investigation.
 
Manufacturer Narrative
(b)(4).Method: the complaint rt265 infant dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare and was visually inspected.Results: visual inspection revealed that the straight connector on the expiratory limb was cracked across the entire length of the collar.A lot check revealed one other complaint of a similar nature for lot date 130612.Conclusion: we were unable to determine what has caused the connector to crack.However, please note that our user instructions clearly specify that the circuits are for a 7 day use only; the complaint states this fault was found after three weeks of use.The hospital also reported that the connector was dropped.All rt265 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The hospital reported that the breathing circuit was used for three weeks prior to the observed cracking.This suggests that the complaint circuit was within specification prior to being released for distribution.The user instructions that accompany the rt265 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." "this product is intended to be used for a maximum of 7 days.".
 
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare field representative that the patient end connector on the expiratory limb of an rt265 infant dual-heated evaqua2 breathing circuit cracked when they dropped it.The breathing circuit had been in use for approximately 3 weeks.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 LIMITED
15 maurice paykel place
east tamaki
auckland, auckland 2013
NZ  2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland, auckland 2013
NZ   2013
Manufacturer Contact
raymond yan
15365 barranca parkway
irvine, CA 92618-2216
MDR Report Key3687114
MDR Text Key4240550
Report Number9611451-2014-00243
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 Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT265
Device Catalogue NumberRT265
Device Lot Number130612
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received02/17/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
HUMMING X VENTILATOR; HUMMING X VENTILATOR
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