CARE-E-VAC II 753790

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-14 for CARE-E-VAC II 753790 manufactured by Hill-rom.

Event Text Entries

[80057768]
Patient Sequence No: 1, Text Type: N, H10


[80057769] During a rapid response, attempts were made to use the suction machine from the code cart. The suction provided was inadequate and supplies were obtained for the wall suction. Code completed with wall suction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6714193
MDR Report Key6714193
Date Received2017-07-14
Date of Report2017-07-05
Date of Event2017-07-02
Report Date2017-07-05
Date Reported to FDA2017-07-05
Date Reported to Mfgr2017-07-05
Date Added to Maude2017-07-14
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

Brand NameCARE-E-VAC II
Generic NamePUMP, PORTABLE, ASPIRATION
Product CodeBTA
Date Received2017-07-14
Model Number753790
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHILL-ROM
Manufacturer Address1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006


Patients

Patient NumberTreatmentOutcomeDate
10 2017-07-14

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