• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL-HEATED EVAQUA 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
 

FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE Back to Search Results
Model Number RT340
Event Date 08/21/2012
Event Type  Malfunction  
Event Description

A hospital in (b)(6) reported that there was a leak in the expiratory limb of an rt340 adult dual-heated evaqua breathing circuit after 2 days of use causing the evita 4 ventilator to alarm. No patient consequence was reported.

 
Manufacturer Narrative

(b)(4). The complaint device has been returned to the manufacturer. Evaluation is anticipated and we are currently attempting to obtain further detailed information. We will provide a follow up report upon completion of our investigation.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT
Type of DeviceBZE
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NEW ZEALAND 2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NEW ZEALAND 2013
Manufacturer Contact
raymond yan
15365 barranca parkway
irvine , CA 92618-2216
9494534000
MDR Report Key2753562
Report Number9611451-2012-00658
Device Sequence Number1
Product CodeBZE
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 08/24/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberRT340
Device Catalogue NumberRT340
Device LOT NumberNP
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/10/2012
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/24/2012
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 TREATMENT DATA
Date Received: 09/21/2012 Patient Sequence Number: 1
Treatment
EVITA 4 VENTILATOR
EVITA 4 VENTILATOR
-
-