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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION/BD RESUS, PED W/MASK, 40" TBG, P/O, 6/CS MANUAL EMERGENCY VENTILATOR

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CAREFUSION/BD RESUS, PED W/MASK, 40" TBG, P/O, 6/CS MANUAL EMERGENCY VENTILATOR Back to Search Results
Catalog Number 2K8008
Device Problem Fracture (1260)
Patient Problem Hypoxia (1918)
Event Date 05/26/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) initial emdr submission (b)(4) has reached out to customer to provide the complaint device for further investigation. (b)(6) label was provided to the customer. At this time we are currently waiting for the sample. Once the investigation is complete or if we receive any additional information we will provide a follow up emdr. (b)(4).
 
Event Description
Medwatch report #2300170000-2016-8023 states: while getting off the elevator to transport the patient to the room, the patient coughed and it was noted that her et tube had been displaced. The crna and surgeon then began to try to ventilate the patient with mask/resus bag and it was then noted that the mask was in the trash and when obtained it appeared to be stepped on because there was a large hole that was not there prior. This is what the patient safety report stated: upon transport to the picu from outpatient surgery, the patient's endotracheal tube became dislodged; when the patient coughed. The patient and team were preparing to come off the elevator into the picu when the tube was noted to be in place. At that point the patient was bagged with mask/resus bag, and immediately ran into room where picu staff was waiting. Upon trying to bag the patient, it was noted that the mask had a crack in it and therefore adequate air exchange was not happening, so a new mask was exchanged out. The picu staff was then able to gain adequate spo2, and they were able to re-intubate the patient.
 
Manufacturer Narrative
Results of investigation: the affected sample was received for investigation, and during our visual inspection the cracked condition was observed; therefore the reported failure mode was confirmed. Carefusion/bd was unable to review the device history record as the lot number was unavailable. Two years of complaints were reviewed and no trend was detected. Upon review of our manufacturing procedure we did not find any deficiencies that would lead to this type of failure. Based on the investigation carefusion/bd is unable to determine a root cause; there is no evidence that the cracked condition on the mask occurred during the manufacturing process. It is probable that this may have happened outside the manufacturing process; such as during shipping and handling.
 
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Brand NameRESUS, PED W/MASK, 40" TBG, P/O, 6/CS
Type of DeviceMANUAL EMERGENCY VENTILATOR
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
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key5854987
MDR Text Key51442997
Report Number8030673-2016-00202
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2K8008
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 Received10/20/2016
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

Patient Treatment Data
Date Received: 08/08/2016 Patient Sequence Number: 1
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