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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL-HEATED BREATHING CIRCUIT; BTT

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FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL-HEATED BREATHING CIRCUIT; BTT Back to Search Results
Model Number RT210
Device Problems Disconnection (1171); Leak/Splash (1354); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 our investigation.
 
Event Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative, that the heater wire moulded plug of three rt210 adult dual-heated breathing circuits disconnected during use.There was no patient consequence.
 
Event Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative, that the heater wire moulded plug of three rt210 adult dual-heated breathing circuits disconnected during use.There was no patient consequence.
 
Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
 
Event Description
A healthcare facility in ohio reported via a fisher & paykel healthcare (f&p) field representative, that the heater wire moulded plug of three rt210 adult dual-heated breathing circuits disconnected during use.There was no patient consequence.
 
Manufacturer Narrative
(b)(4), method: the complaint rt210 adult dual-heated breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photographs provided by the customer, and our knowledge of the product.Results: visual inspection of the photographs revealed that the expiratory heater wire moulded plug of rt210 circuit was loose.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.All breathing circuits are visually inspected and pressure tested before leaving the production line, and those that fail are rejected.The subject breathing circuits would have met the required specifications at time of production.The user instructions that accompany the rt210 adult dual-heated breathing circuitt 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 connection to a patient.Ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.Visually inspect breathing sets for damage before use and replace if damaged.
 
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Brand Name
ADULT DUAL-HEATED BREATHING CIRCUIT
Type of Device
BTT
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
faranak gomarooni
173 technology dr.
suite 100
irvine, CA 92618
9494534000
MDR Report Key13237486
MDR Text Key286011393
Report Number9611451-2022-00013
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K983112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/20/2021
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 NumberRT210
Device Catalogue NumberRT210
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/20/2021
Initial Date FDA Received01/12/2022
Supplement Dates Manufacturer Received02/14/2022
Supplement Dates FDA Received02/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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