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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC RESUS, PED W/MASK, LRG TBG, P/O, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT

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CAREFUSION, INC RESUS, PED W/MASK, LRG TBG, P/O, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Catalog Number 2K8018
Device Problem Failure to Disconnect (2541)
Patient Problems Apnea (1720); Low Oxygen Saturation (2477)
Event Date 01/31/2017
Event Type  Injury  
Manufacturer Narrative
Initial emdr submission: no sample available for this complaint. If any additional information becomes available a follow up submission will be filed. (b)(4).
 
Event Description
Customer reported the following via medwatch report (b)(4). "the patient had a desaturation episode to the 60's during a treatment. The respiratory therapist went to use the resuscitation bag and mask, but the mask size was wrong and it was not able to disconnect the mask from bag to switch to a different size. Customer confirmed that the mask was the wrong size for the patient but it was the mask that comes attached to the resuscitation bag the connector piece to the mask was stuck. The patient had an apneic event".
 
Manufacturer Narrative
No sample was provided for evaluation. At this time we are unable to confirm the reported issue. However, based on similar complaint investigations, a probable root cause is related to the current mirror finish surface on the elbow, which makes the mask very difficult to remove. Capa was opened to further investigate this issue. Capa (b)(4). The elbow will now contain a textured finish to allow the mask to be easily removed from the elbow.
 
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Brand NameRESUS, PED W/MASK, LRG TBG, P/O, 6/CS
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway dr
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
cerrada vía de la producción
no.85 parque industrial
mexicali baja california norte
MX
Manufacturer Contact
mindy faber
75 north fairway drive
vernon hills, IL 60061
MDR Report Key6494308
MDR Text Key72844847
Report Number8030673-2017-00323
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8018
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/14/2017 Patient Sequence Number: 1
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