• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION/BD 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
One opened sample was returned for further evaluation. A visual inspection was performed and it was observed that the sample did not exhibit the textured surface finish on the connectors outer diameter. The textured surface makes it easier to detach the mask form the elbow. The prior design had a smooth mirror finish as exhibited on this sample. It was found that this mirror finish on the elbow and the smooth finish on the mask can create a vacuum effect making the removal of the mask difficult. A design change has been made to this product adding the texturized surface to the elbow eliminating the difficult remove failure mode.
 
Manufacturer Narrative
Carefusion has received the complaint sample and is in the process of doing a full evaluation. Once the investigation is complete or if we receive any additional information we will provide a follow up emdr. (b)(4).
 
Event Description
Customer reported the following via medwatch report number (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".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESUS, PED W/MASK, LRG TBG, P/O, 6/CS
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
CAREFUSION/BD
cerrada vía de la producción
no.85 parque industrial
mexicali baja california norte
MX
Manufacturer (Section G)
CAREFUSION/BD
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 Key6491298
MDR Text Key110217489
Report Number8030673-2017-00321
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,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/13/2017 Patient Sequence Number: 1
-
-