BIRD 04230

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-11-06 for BIRD 04230 manufactured by Bird Products Corp..

Event Text Entries

[239034] Pt was receiving aggressive hemodynamic stabilization measures including central venous line, fluid resuscitation and pressors. In 2001, pt experienced cardiopulmonary failure and was started on estracorporeal membrane oxygenation cannulation. A pop-off valve was placed in the ventilating gas tubing proximal to the gas phase of the artificial lung, to prevent air embolus if occlusion of the outlet gas phase occurs. The co2 content in the pt's blood occurred before and after the oxygenation. When the pop-off valve was removed, the pco2 level on the pt and ecmo circuit decreased. The pop-off valve was measured and recorded to pop off at 30cm h20.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number359922
MDR Report Key359922
Date Received2001-11-06
Date of Report2001-05-23
Date of Event2001-02-14
Report Date2001-05-23
Date Reported to Mfgr2001-06-14
Date Added to Maude2001-11-16
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBIRD
Generic NameVALVE, RELIEF, 30 CMH2O
Product CodeMNJ
Date Received2001-11-06
Model Number04230
Catalog Number04230
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key349105
ManufacturerBIRD PRODUCTS CORP.
Manufacturer Address1100 BIRD CENTER DR. PALM SPRINGS CA 92262 US
Baseline Brand NameBIRD
Baseline Generic NameVALVE, RELIEF, 30CM H2O
Baseline Model No04230
Baseline Catalog No04230
Baseline Device FamilyPT CIRCUITS AND COMPONENTS
Baseline Shelf Life ContainedN
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2001-11-06

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