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U.S. Department of Health and Human Services

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

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CAREFUSION AIRLIFE VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Catalog Number 2K8005
Device Problem Disconnection (1171)
Patient Problem Low Oxygen Saturation (2477)
Event Date 03/25/2017
Event Type  malfunction  
Event Description
Self-inflating ventilation bag was connected to oxygen source and patient was ventilated after intubation. The patient experienced decreasing oxygen saturation despite ventilation. Troubleshooting the issue revealed that the oxygen tubing had disconnected from the connection to the bag, which is inside a corrugated reservoir tubing. The patient was not receiving additional oxygen as intended. The equipment issue was found quickly, and new equipment was readily available, swapped out and the patient responded quickly. No patient harm. Manufacturer response for self-inflating ventilation bag, airlife (per site reporter): responder was unaware of similar situations. Requested return of affected device and is sending a shipping box.
 
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Brand NameAIRLIFE
Type of DeviceVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
CAREFUSION
75 n fairway dr.
vernon hills IL 60061
MDR Report Key6459764
MDR Text Key71694555
Report Number6459764
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 03/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2017
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8005
Other Device ID NumberCF30-104
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/29/2017
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer03/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/05/2017 Patient Sequence Number: 1
Treatment
NO
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