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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION BIRD; MIXER, BREATHING GASES, ANESTHESIA INHALATION/BZR

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CAREFUSION BIRD; MIXER, BREATHING GASES, ANESTHESIA INHALATION/BZR Back to Search Results
Model Number MICROBLENDER
Device Problem No Audible Alarm (1019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2014
Event Type  Injury  
Event Description
The following description of the event was copied from a carefusion ventilation complaint form submitted on behalf of user facility in (b)(6) by the distributor in (b)(6)."hospital med tech department has checked blender gas alarm function, after they have heard from user at their hospital that during a pt transport in (b)(6), gas alarm didn't work properly.Someone forgot to turn on the oxygen bottle, only air.According to [name removed], they didn't know pn/sn.They have not received any report of any pt harm.".
 
Manufacturer Narrative
Carefusion does not have any info at present in regards to the effect of the lack of supplemental oxygen on the pt during the reported event.As the lack of supplemental oxygen could cause a serious injury, carefusion has decided to report this event as a serious injury.Neither the foreign user facility nor the foreign distributor submitted a user facility/importer report to the manufacturer.Event codes were derived based on info provided by the foreign distributor.(b)(4).The foreign user facility determined that the cause of the pt only receiving air during transport was that one of their staff did not turn on the oxygen cylinder to provide oxygen to the device additionally, as a contributing factor to the event it appears as though the staff did not heed the following warnings in the micro-blender instruction manual: the pt gas must be monitored with an oxygen analyzer.Adjustment of the oxygen concentration must be verified using an oxygen analyzer.The foreign user facility also determined that the most likely cause of the reported gas alarm not working was a malfunctioning alarm cap assembly.Carefusion is attempting of gather additional info regarding the reported event, disposition of the pt and info on any evaluation of the device performed by the foreign user facility.Based on the info that carefusion has at present it does not appear that the foreign user facility documented this event in any type of official report.Therefore they have no record of the device's part number, serial number nor which pt the event occurred on.Should carefusion obtain additional info, a follow-up medwatch report will be submitted.
 
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Brand Name
BIRD
Type of Device
MIXER, BREATHING GASES, ANESTHESIA INHALATION/BZR
Manufacturer (Section D)
CAREFUSION
yorba linda CA
Manufacturer (Section G)
CAREFUSION
1100 bird center dr.
palm springs CA 92262
Manufacturer Contact
james stytle
7608837120
MDR Report Key4462326
MDR Text Key5189219
Report Number2021710-2015-00111
Device Sequence Number1
Product Code BZR
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
ASKU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 08/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMICROBLENDER
Device Catalogue NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Hospital
Initial Date Manufacturer Received 12/23/2014
Initial Date FDA Received01/21/2015
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
ASKU
Patient Outcome(s) Required Intervention;
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