ISU 1251

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-10 for ISU 1251 manufactured by Ohio Medical Corporation.

Event Text Entries

[44792259]
Patient Sequence No: 1, Text Type: N, H10


[44792260] The vacuum regulator comes loose from wall outlet. At times the regulator leans forward compromising suction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number5642878
MDR Report Key5642878
Date Received2016-05-10
Date of Report2016-04-25
Date of Event2016-02-05
Report Date2016-04-25
Date Reported to FDA2016-04-25
Date Reported to Mfgr2016-04-25
Date Added to Maude2016-05-10
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameREGULATOR, VACUUM
Product CodeKDP
Date Received2016-05-10
Model NumberISU 1251
OperatorPHYSICIAN
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOHIO MEDICAL CORPORATION
Manufacturer Address1111 LAKESIDE DR. GURNEE IL 60031 US 60031


Patients

Patient NumberTreatmentOutcomeDate
10 2016-05-10

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