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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 2200, INC. AIRLIFE VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

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CAREFUSION 2200, INC. AIRLIFE VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Catalog Number 0000943560
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2017
Event Type  malfunction  
Event Description
During rounding the hallways, i was opening the o2 tubing to prepare for the stretchers and found a package that was missing the peep valve. We took the tubing and wrapping and gave it to manager. Manufacturer response: for inflating resuscitation device with peep valve, (brand not provided) (per site reporter) requested to mail to rep home so he could file complaint.
 
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Brand NameAIRLIFE
Type of DeviceVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
CAREFUSION 2200, INC.
75 n fairway dr.
vernon hills IL 60061
MDR Report Key6463431
MDR Text Key71878811
Report Number6463431
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2017
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0000943560
Device Lot Number10885403293931
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/27/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer03/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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