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

MAUDE Adverse Event Report: CAREFUSION, INC RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS MANUAL EMERGENCY VENTILATOR

  • 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, INC RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS MANUAL EMERGENCY VENTILATOR Back to Search Results
Catalog Number 2K8032
Device Problem Separation Failure (2547)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/10/2016
Event Type  Injury  
Manufacturer Narrative
At this time, the customer has not responded to requests for additional information regarding this event. If additional information becomes available, it will be submitted in a follow up report. (b)(4). At this time, carefusion has not received the suspect device/component for evaluation.
 
Event Description
Upon checking of the returned item, the mask is very hard to detach from the bag, during emergency cases, the mask should be easily detached to connect the bag to the endotracheal tube. The issue was discovered during an intubation procedure in the emergency room department. They were unable to detach the face mask from the bag when they need to attach it to the endotracheal tube. Customer confirms no patient harm.
 
Manufacturer Narrative
Unfortunately the sample or a photo was not provided or available for evaluation. The failure mode reported at this time cannot be confirmed. The device history record for the lot reported was evaluated for any issues related with this customer report and no issues were found. The product was manufactured, inspected and released in accordance with our internal procedures. Without a sample available for evaluation we are unable to determine if personnel contributed to this failure. The current product line is running according to procedure. In addition, our quality personnel routinely check the product visually and functionally to assess for any defects or issues. Based on the investigation, at this time it¿s not possible to determine a root cause for the issue reported on product since the sample was not available for evaluation. Even though the issue reported could not be confirmed since no sample was available for evaluation, production personnel were notified of this failure reported.
 
Manufacturer Narrative
Follow up submission correction on investigation results. A reevaluation was completed on the device history record for the issue reported. This evaluation determined that the finished good lot number reported had no issues. However, through the review it was identified that the supplied mask component with part number 75-10012 within the finished good lot number was found to have a issue with the 22mm fitting and a scar was initiated to the supplier for this issue. The scar result from the supplier determined that the mask component with part number 75-10012 has an issue with the material at not being thermally stable which can cause variations in the dimension of the mask after manufacturing or during temperature changes during shipping. This would result that when the mask is assembled with the elbow, throughout time the mask could not get disconnected easily. To correct this issue, carefusion has changed suppliers for the mask. In addition, routine visual and functional tests are conducted prior to final packaging to assess for any defects or issues.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS
Type of DeviceMANUAL EMERGENCY VENTILATOR
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
cerrada vía de la producción
no. 85., parque industrial mex
mexicali baja california norte
MX
Manufacturer Contact
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
7149227830
MDR Report Key5990450
MDR Text Key56037983
Report Number8030673-2016-00237
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeRP
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8032
Device Lot Number778846
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2016
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 Unkown

Patient Treatment Data
Date Received: 09/30/2016 Patient Sequence Number: 1
-
-