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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

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CAREFUSION, INC. RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS MANUAL EMERGENCY VENTILATOR Back to Search Results
Catalog Number 2K8032
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) initial emdr submission. Samples has been requested from customer. We are currently awaiting for the sample return. Once the sample is received we will investigate this sample. If any additional information becomes available or once the investigation is complete a follow up emdr will be submitted.
 
Event Description
Customer reported via email: "bag part of the resuscitator, easily detaches from the collar during ventilation. Unable to provide demographics of patient involved. No injury for the patient but the clinician had to put her hand around the edge of the bag to contain the air leak until she could have another ambubag. No additional treatment was provided to the patient. The clinical status of the patient is stable. ".
 
Manufacturer Narrative
(b)(4). Twelve samples were received for evaluation; during visual inspection it was observed that between the resuscitator and housing 6 of the samples contained uv glue which was not cured, 4 eaches had uv glue which was not applied properly, and 2 eaches were detached. Additionally, the housing 30mm exhalation port with p/n: 65-4213e was submitted to ir scan in order to determine if the samples received for evaluation correspond to resin k or if another characteristic was present which could cause the housing to detach from the resuscitator. In result, no differences were detected between the three reference materials submitted. The device history record for the lot reported was evaluated for any issues related to the reported issue. The product was manufactured, inspected and released in accordance with all internal procedures and no issues were observed. Two years of complaints were reviewed from july 1, 2014 - june 30, 2016 and no trend was detected. It is possible that personnel could be related to this failure, however, due to inconclusive results of the investigation (b)(4) has been created to further define the final root cause and potential corrective actions. The complaint will be closed at this time and (b)(4) may be referenced.
 
Event Description
Customer reported via email: "bag part of the resuscitator, easily detaches from the collar during ventilation. Unable to provide demographics of patient involved. No injury for the patient but the clinician had to put her hand around the edge of the bag to contain the air leak until she could have another ambubag. No additional treatment was provided to the patient. The clinical status of the patient is stable. ".
 
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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 via de la produccion
no. 85, parque industrial mex
mexicali baja california norte
MX
Manufacturer Contact
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key5621134
MDR Text Key44998788
Report Number8030673-2016-00166
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8032
Device Lot Number806122
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2016
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?
Type of Device Usage

Patient Treatment Data
Date Received: 04/29/2016 Patient Sequence Number: 1
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