N/A 11165

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-05-28 for N/A 11165 manufactured by Ascent Halthcare Solutions.

Event Text Entries

[1504769] It was reported that the device would not hold pressure. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5


[8627387] At the time of this report the device investigation has not been completed. Once the investigation is completed a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1056128-2010-00024
MDR Report Key1702456
Report Source05,06,07
Date Received2010-05-28
Date of Report2010-07-15
Date Mfgr Received2010-06-18
Device Manufacturer Date2009-11-30
Date Added to Maude2011-04-07
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 FDA0
Event Location0
Manufacturer ContactMS. MOIRA BARTON-VARTY
Manufacturer Street10232 S. 51ST STREET
Manufacturer CityPHOENIX AZ 85044
Manufacturer CountryUS
Manufacturer Postal85044
Manufacturer Phone4807635300
Manufacturer G1ASCENT HALTHCARE SOLUTIONS
Manufacturer Street5307 GREAT OAK DRIVE
Manufacturer CityLAKELAND FL 33815
Manufacturer CountryUS
Manufacturer Postal Code33815
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameN/A
Generic NameN/A
Product CodeNMF
Date Received2010-05-28
Returned To Mfg2010-05-17
Model Number11165
Catalog Number11165
Lot Number878402
Device Expiration Date2010-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASCENT HALTHCARE SOLUTIONS
Manufacturer Address5307 GREAT OAK DRIVE LAKELAND FL 33815 US 33815


Patients

Patient NumberTreatmentOutcomeDate
10 2010-05-28

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