Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE Back to Search Results
Model Number RT265
Device Problems Material Disintegration (1177); Leak/Splash (1354); Gas/Air Leak (2946)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).We are currently attempting to retrieve the complaint device for investigation.We will provide a follow up report upon completion of our investigation.
 
Event Description
A healthcare facility in (b)(6) reported that the rt265 infant dual-heated evaqua2 breathing circuit had a leak in the circuit, and when the circuit was adjusted the outer material "crumbled." there were no reported patient consequences.
 
Event Description
A healthcare facility in nebraska reported that the rt265 infant dual-heated evaqua2 breathing circuit had a leak in the circuit, and when the circuit was adjusted the outer material "crumbled." there were no reported patient consequences.
 
Manufacturer Narrative
(b)(4).Method: the complaint rt265 infant dual-heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare for evaluation.Our investigation is 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 tubing was degraded.Conclusion: we are unable to determine what caused the degradation of the complaint circuit.Based on the previous investigation, degradation of the breathing circuits can be due to a number of reasons, including the contact with chemicals or possible exposure to uv light for a longer period of time.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 subject breathing circuit would have met the specification at the time of production.The user instructions that accompany the rt265 infant dual-heated evaqua2 breathing circuit state: do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.Do not use medications containing tyloxapol (such as tacholiquin) as this may damage the tubing and lead to a loss of ventilation pressure.Set appropriate ventilator alarms.
 
Event Description
A healthcare facility in nebraska reported that the rt265 infant dual-heated evaqua2 breathing circuit had a leak in the circuit, and when the circuit was adjusted the outer material "crumbled." there were no reported patient consequences.
 
Manufacturer Narrative
(b)(4).The complaint device was later returned to fisher & paykel healthcare (f&p) in new zealand, following the submission of follow up report #1.Section d10, h3, h6 and h10 have been updated.Method: the complaint rt265 infant dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare in new zealand for evaluation where it was visually inspected.Results: visual inspection of the complaint device confirmed that the tubing was discoloured and had multiple degraded areas along the length of the tubing.Conclusion: we are unable to determine what caused the degradation of the complaint circuit.Based on the previous investigation, degradation of the breathing circuits can be due to a number of reasons, including the contact with chemicals or possible exposure to uv light for a longer period of time.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 subject breathing circuit would have met the specification at the time of production.The user instructions that accompany the rt265 infant dual-heated evaqua2 breathing circuit state: do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers.Do not use medications containing tyloxapol (such as tacholiquin) as this may damage the tubing and lead to a loss of ventilation pressure.Set appropriate ventilator alarms.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Type of Device
BZE
MDR Report Key9767548
MDR Text Key184633049
Report Number9611451-2020-00215
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 health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT265
Device Catalogue NumberRT265
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2020
Date Manufacturer Received11/04/2020
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
-
-