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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER AND PAYKEL EVAQUA 2 INFANT CIRCUIT

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FISHER AND PAYKEL EVAQUA 2 INFANT CIRCUIT Back to Search Results
Catalog Number RT265
Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979); Pressure Problem (3012)
Patient Problems Unspecified Infection (1930); Scar Tissue (2060)
Event Date 08/25/2014
Event Type  Injury  
Event Description
The fisher and paykel evaqua 2 infant circuit (cat# rt265) has the potential to cause pressure sores/ulcers, redness and prolong hospital stays if wound care is needed. The circuit when used in a bubble cpap configuration has a rigid high protruding pressure line port that can puncture through a premies skin with minimal effort thus causing severe scarring, possible infection portal and possible death if treatment is ineffective. I highly recommend as a staff therapist and seeing this first hand that fisher and paykel add an extra 12 inch flex tube to avoid this problem. Diagnosis or reason for use: to provide non-invasive support to premature babies.
 
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Brand NameEVAQUA 2
Type of DeviceINFANT CIRCUIT
Manufacturer (Section D)
FISHER AND PAYKEL
irvine 92618
MDR Report Key4048442
MDR Text Key4814129
Report NumberMW5037971
Device Sequence Number1
Product Code BZE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRT265
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes

Patient Treatment Data
Date Received: 08/26/2014 Patient Sequence Number: 1
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