HUDSON VOLDYNE 5000 VOLUMETRIC EXERCISER 8884719009

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 2015-09-22 for HUDSON VOLDYNE 5000 VOLUMETRIC EXERCISER 8884719009 manufactured by Teleflex Medical.

Event Text Entries

[26447355] (b)(4). A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned. The device history record investigation did not show issues related to complaint. A document assessment (fmea) was conducted and no changes required. Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect. At this time since the sample is not available it is not possible to determine the source of the defect reported. Customer complaint cannot be confirmed since the device sample is not available to perform a proper investigation and determine the root cause. If the device sample becomes available at a later date, this complaint will be updated accordingly. Teleflex will continue to monitor and trend on similar complaints.
Patient Sequence No: 1, Text Type: N, H10


[26447356] The customer alleges that the device is leaking during treatment. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003898360-2015-00670
MDR Report Key5095292
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2015-09-22
Date of Report2015-09-14
Date of Event2015-09-14
Date Mfgr Received2015-09-14
Device Manufacturer Date2015-04-13
Date Added to Maude2015-09-22
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 ContactMARGIE BURTON, RN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334965
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetRANCHO EL DESCANSO
Manufacturer CityTECATE 21478
Manufacturer CountryMX
Manufacturer Postal Code21478
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON VOLDYNE 5000 VOLUMETRIC EXERCISER
Generic NameINCENTIVE SPIROMETER
Product CodeBWF
Date Received2015-09-22
Catalog Number8884719009
Lot Number73D1500192
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2015-09-22

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