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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT
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ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT Back to Search Results
Model Number RT100
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint rt100 adult breathing circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.
 
Event Description
A distributor reported on behalf of a healthcare facility in (b)(6), via a fisher & paykel (f&p) field representative that the dryline connector of a rt100 adult breathing circuit was found to be deformed.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).The subject device is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.Method: two complaint rt100 adult breathing circuits were returned to fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Results: visual inspection revealed that one of the two returned complaint devices' connector was found to be deformed.Conclusion: we are unable to determine the cause of the deformed connector.All rt100 adult breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject adult breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt100 adult 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.".
 
Event Description
A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel (f&p) field representative that the dryline connector of two rt100 adult breathing circuit were found to be deformed.There was no patient involvement.
 
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Brand Name
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
Type of Device
BTT
MDR Report Key11662516
MDR Text Key247488327
Report Number9611451-2021-00417
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT100
Device Catalogue NumberRT100
Device Lot Number2101143014
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2021
Date Manufacturer Received05/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2020
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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