FDA.reportPublic FDA data

MAUDE MDR 2966649

MDR report key
2966649
Report number
8030673-2013-00010
Event key
0
Event type
3
Date of event
2013-01-24
Date received
2013-02-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JILL RITTORNO
Address
1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US
Phone
847-847-8474
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MASK AIR ENTRAIN ADULT 50/CSMASK, OXYGEN, LOW CONCENTRATION, VENTURICAREFUSIONBYF001240-A000493387R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-02-180

Event Narratives#

N

Patient 1

(B)(4). EVALUATION SUMMARY: A 50% VENTI ADAPTER WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, WE CONFIRMED THE OCCLUSION IN THIS ADAPTER. THE ADAPTER IS A SUPPLIED COMPONENT TO CAREFUSION. THE SUPPLIER THAT MANUFACTURES THIS PART WAS NOTIFIED OF THE DEFECT. A PROJECT INITIATION WAS REQUESTED TO THE SUPPLIER BY CAREFUSION TO DETERMINE THE ROOT CAUSE FOR THE ADAPTER BEING OCCLUDED. CAREFUSION PLANS TO IMPLEMENT ADDITIONAL QUALITY INSPECTIONS AT THE ASSEMBLY LINE PROCESS IN ORDER TO IMMEDIATELY DETECT THIS TYPE OF FAILURE IF IT WERE TO RECUR.

D

Patient 1

CUSTOMER REPORTED ON (B)(6) 2013, AN ADDITIONAL ADAPTER THAT WAS VISUALLY CONFIRMED TO BE OCCLUDED. THIS CONDITION OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. ?NO PATIENT INJURY WAS REPORTED.

N

Patient 1

(B)(4): THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF CAREFUSION'S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED.