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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE
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INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE Back to Search Results
Model Number RT266
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of investigation.
 
Event Description
A distributor in japan reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that a rt266 infant dual-heated evaqua2 breathing circuit did not pass the leak test before use.There was no patient involvement.
 
Event Description
A distributor in japan reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that a rt266 infant dual-heated evaqua2 breathing circuit did not pass the leak test before use.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).Method: the complaint rt266 infant dual-heated evaqua2 breathing circuit swivel was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected.The swivel was also pressure tested by connecting to a functional breathing circuit.Results: visual inspection revealed no damage to the subject rt266 swivel.The pressure test was also found to be within specification.Conclusion: we were unable to determine what may have caused the failed leak test, as no fault was found with the returned swivel.All rt266 infant dual heated evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuit would have met the required specifications at the time of production.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.".
 
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Brand Name
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Type of Device
BZE
MDR Report Key12236226
MDR Text Key265796746
Report Number9611451-2021-00870
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
PMA/PMN Number
K103767
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT266
Device Catalogue NumberRT266
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2021
Initial Date Manufacturer Received 06/28/2021
Initial Date FDA Received07/28/2021
Supplement Dates Manufacturer Received08/29/2021
Supplement Dates FDA Received09/27/2021
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
Patient Sequence Number1
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