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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NON-HEATED ADULT BREATHING CIRCUIT; BTT
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NON-HEATED ADULT BREATHING CIRCUIT; BTT Back to Search Results
Model Number RT134
Device Problems Leak/Splash (1354); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Ps340124.The complaint rt134 adult breathing circuit is currently en routee to fisher & paykel healthcare in new zealand for investigation.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) that an rt134 adult breathing circuit did not pass the ventilator leak test before use.There was no patient involvement.
 
Manufacturer Narrative
Ps340124.Method: the complaint rt134 non-heated adult breathing circuit was returned to fisher & paykel healthcare in new zealand for evaluation where it was visually inspected.Results: visual inspection revealed that the top of the water bowl was found to be broken.Conclusion: the reported event is likely as a result of the broken water bowl.We are unable to determine the cause of the broken water bowl.The water trap of the breathing circuit consists of two parts, a lid and a bowl, which can be separated to allow the caregiver to empty the water trap.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.This suggests that any leak must have developed after the breathing circuit was released for distribution, during transport, storage or use, possibly by distortion of the water trap when the bowl was connected.The user instructions that accompany the rt134 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 that an rt134 adult breathing circuit did not pass the ventilator leak test before use.There was no patient involvement.
 
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Brand Name
NON-HEATED ADULT BREATHING CIRCUIT
Type of Device
BTT
MDR Report Key10141431
MDR Text Key199321593
Report Number9611451-2020-00530
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012430533
UDI-Public010942001243053310
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Type of Report Initial,Followup
Report Date 05/12/2020
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 NumberRT134
Device Catalogue NumberRT134
Device Lot Number2100796519
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2020
Initial Date Manufacturer Received 05/12/2020
Initial Date FDA Received06/10/2020
Supplement Dates Manufacturer Received06/25/2020
Supplement Dates FDA Received07/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2019
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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