RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS 2K8032

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-04-07 for RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS 2K8032 manufactured by Carefusion/bd.

Event Text Entries

[72124459] (b)(4). It has been confirmed by carefusion/bd that the complaint sample is not available for evaluation. Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device. If a sample or any additional information becomes available a follow up emdr will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[72124460] The customer reported an? Issue with removing the face mask from current resuscitation bag. The staff member was trying to resuscitate a patient via endotracheal tube?. Customer reported no patient harm.
Patient Sequence No: 1, Text Type: D, B5


[74380374] Follow up submission: no sample was provided for evaluation. At this time we are unable to confirm the reported issue. However, based on similar complaint investigations, a probable root cause is related to the current mirror finish surface on the elbow, which makes the mask very difficult to remove. Capa was opened to further investigate this issue. Capa (b)(4). The elbow will now contain a textured finish to allow the mask to be easily removed from the elbow.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8030673-2017-00318
MDR Report Key6472554
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-04-07
Date of Report2017-04-26
Date of Event2017-03-07
Date Mfgr Received2017-04-20
Date Added to Maude2017-04-07
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 FDA3
Event Location3
Manufacturer ContactMINDY FABER
Manufacturer Street75 NORTH FAIRWAY DRIVE
Manufacturer CityVERNON HILLS IL 60061
Manufacturer CountryUS
Manufacturer Postal60061
Manufacturer G1CAREFUSION/BD
Manufacturer StreetCERRADA V NO.85 PARQUE INDUSTRIAL
Manufacturer CityMEXICALI BAJA CALIFORNIA NORTE
Manufacturer CountryMX
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS
Generic NameCARDIOPULMONARY RESUSCITATION AID KIT
Product CodeOEV
Date Received2017-04-07
Catalog Number2K8032
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION/BD
Manufacturer AddressCERRADA V?A DE LA PRODUCCI?N NO.85 PARQUE INDUSTRIAL MEXICALI BAJA CALIFORNIA NORTE MX


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-04-07

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