MASK AIR ENTRAIN ADULT 50/CS 001240-A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-18 for MASK AIR ENTRAIN ADULT 50/CS 001240-A manufactured by Carefusion.

Event Text Entries

[3330599] 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.
Patient Sequence No: 1, Text Type: D, B5


[10460601] (b)(4): the device has been received for evaluation. Upon completion of carefusion's investigation a follow up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[10525103] (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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8030673-2013-00011
MDR Report Key2966651
Report Source05
Date Received2013-02-18
Date of Report2013-01-24
Date of Event2013-01-24
Date Mfgr Received2013-03-01
Date Added to Maude2013-04-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJILL RITTORNO
Manufacturer Street1500 WAUKEGAN ROAD
Manufacturer CityMCGAW PARK IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8474737294
Manufacturer G1PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V
Manufacturer StreetCERRADA VIA DE LA PRODUCCION NO85PARQUE INDUST.MEXICALI III
Manufacturer CityMEXICALI 21600
Manufacturer CountryMX
Manufacturer Postal Code21600
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMASK AIR ENTRAIN ADULT 50/CS
Generic NameMASK, OXYGEN, LOW CONCENTRATION, VENTURI
Product CodeBYF
Date Received2013-02-18
Returned To Mfg2013-02-14
Model Number001240-A
Lot Number000493387
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION
Manufacturer Address1500 WAUKEGAN RD MCGAW PARK IL 60085 US 60085


Patients

Patient NumberTreatmentOutcomeDate
10 2013-02-18

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