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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION/BD RESUS,ADLT,MSK,TUBE RSV,PEEP,MANO,7' TBG CARDIOPULMONARY RESUSCITATION AID KIT

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CAREFUSION/BD RESUS,ADLT,MSK,TUBE RSV,PEEP,MANO,7' TBG CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Model Number 2K8035M
Device Problem Failure to Disconnect (2541)
Patient Problem Death (1802)
Event Date 09/21/2015
Event Type  Death  
Manufacturer Narrative
(b)(4) sample evaluation summary: one open sample was received it was evaluated according to our inspection procedure and did not present any visual problems. In additional the sample was submitted for a dimensional inspection, and no problems were found. The device history record for the lot reported was evaluated for any issues related with this customer report. The product was manufactured, inspected and released in accordance with our internal procedures and no issues were observed. Two years of complaints were reviewed from december 1, 2013 - november 30, 2015 and no trend was observed. Since the issue reported cannot be confirmed (the sample does not present any anomalies) it is not possible to determine the root cause of the issue reported. No corrective action will be implemented since the failure reported was not confirmed during sample evaluation. (b)(4).
 
Event Description
Customer stated that the mask will not come off the elbow. When the therapist went to remove the mask to continue to ventilate the patient after intubation, the mask would not come off. A new resuscitation bag was obtained. The patient came in the emergency room with cpr being performed. The patient did regain a heart rate and was intubated but passed away shortly after intubating. Customer confirmed that the patient's death was not due to product failure. "we were unsuccessful at maintaining a heart rate".
 
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Brand NameRESUS,ADLT,MSK,TUBE RSV,PEEP,MANO,7' TBG
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
jill rittorno
75 north fairway drive
vernon hills, IL 60061
MDR Report Key5825926
MDR Text Key50547160
Report Number8030673-2016-00158
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
Type of Report Initial
Report Date 09/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2K8035M
Device Lot Number0000785469
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2015
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2015
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

Patient Treatment Data
Date Received: 07/27/2016 Patient Sequence Number: 1
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