HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER 5372

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-07-22 for HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER 5372 manufactured by Teleflex Medical.

Event Text Entries

[6055250] The customer alleges that the mask was found deflated on the crash cart. No patient injury or involvement.
Patient Sequence No: 1, Text Type: D, B5


[13512660] (b)(4). The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10


[24808221] (b)(4). The sample was returned for evaluation. A visual exam was performed and it was observed that the hard shell of the mask was deformed and the air cushion was deflated. The air cushion was filled with gas and then submerged in water and the air cushion was pressed by hand. No any bubbles (or leakages) were found. Based on the investigation performed, the reported complaint was confirmed. The mask was manufactured in 2011 and the expiration date was 2014. It was determined that the air leaked naturally during the long time in storage, which caused the deformation of the mask.
Patient Sequence No: 1, Text Type: N, H10


[24808222] The customer alleges that the mask was found deflated on the crash cart. No patient injury or involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1044475-2015-00242
MDR Report Key4932533
Report Source06,USER FACILITY
Date Received2015-07-22
Date of Report2015-06-30
Date of Event2015-04-27
Date Mfgr Received2015-08-25
Date Added to Maude2015-07-22
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 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 DISP MANUAL RESUS,ADULT W/FLOW DIVERTER
Generic NameADULT RESUSCITATION BAG
Product CodeNHK
Date Received2015-07-22
Returned To Mfg2015-07-08
Catalog Number5372
Lot Number1146
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2015-07-22

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