HUDSON FOLDABLE MANUAL RESUS,DISP, ADULT W/FLO 5387

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 2015-08-11 for HUDSON FOLDABLE MANUAL RESUS,DISP, ADULT W/FLO 5387 manufactured by Teleflex Medical.

Event Text Entries

[23356198] Qn# (b)(4). It is unk if the device sample is evaluated.
Patient Sequence No: 1, Text Type: N, H10


[23356199] A customer alleges that the medical staff wanted to use a resuscitation bag for a pt. When opening the code cart for the resuscitation bag and mask, it was discovered that the mask was totally deflated. The device was replaced. No pt injury or harm.
Patient Sequence No: 1, Text Type: D, B5


[26113723] (b)(4). The sample was returned for evaluation. A visual exam was performed and it was observed that the hard shell and the air cushion were damaged. The product was manufactured in 2010 and it was out of the expiration date in 2013. It was determined that the air leaked naturally during the long time in storage or transportation.
Patient Sequence No: 1, Text Type: N, H10


[26113724] The customer alleges that the medical staff wanted to use a resuscitation bag for a patient. When opening the code cart for the resuscitation bag and mask, it was discovered that the mask was totally deflated. The device was replaced. No patient injury or harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1044475-2015-00290
MDR Report Key4999168
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2015-08-11
Date of Report2015-07-21
Date of Event2015-07-20
Date Mfgr Received2015-09-01
Date Added to Maude2015-08-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRESPIRATORY THERAPIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1TELEFLEX MEDICAL
Manufacturer Street2917 WECK DRIVE
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal Code27709
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON FOLDABLE MANUAL RESUS,DISP, ADULT W/FLO
Generic NameRESUSCITATION BAG
Product CodeNHK
Date Received2015-08-11
Returned To Mfg2015-07-31
Catalog Number5387
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC US


Patients

Patient NumberTreatmentOutcomeDate
10 2015-08-11

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