AQUILEX PUMP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-14 for AQUILEX PUMP manufactured by Hologic, Inc.

Event Text Entries

[144956388] The outflow tract would not function, it would not suck up. Checked device afterwards and seemed to be working. Manufacturer response for fluid management system, aquilex pump (per site reporter). Took the unit and shipped a replacement next day.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8607316
MDR Report Key8607316
Date Received2019-05-14
Date of Report2019-05-09
Date of Event2019-04-12
Report Date2019-05-09
Date Reported to FDA2019-05-09
Date Reported to Mfgr2019-05-14
Date Added to Maude2019-05-14
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAQUILEX PUMP
Generic NameINSUFFLATOR, HYSTEROSCOPIC
Product CodeHIG
Date Received2019-05-14
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age9 MO
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC
Manufacturer Address250 CAMPUS DR. MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-14

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