HYPERINFLATION SYSTEM HS34051

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-22 for HYPERINFLATION SYSTEM HS34051 manufactured by Ventlab Llc..

Event Text Entries

[48714541] During a code, the bag broke away from the mask. No injury, no reports.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2246980-2016-00019
MDR Report Key5742571
Date Received2016-06-22
Date of Report2016-06-22
Date of Event2016-06-09
Date Mfgr Received2016-06-09
Date Added to Maude2016-06-22
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 FDA3
Event Location3
Manufacturer ContactMS. CARRIE FORTUNA
Manufacturer Street2710 NORTHRIDGE DR. SUITE A
Manufacturer CityGRAND RAPIDS MI 49544
Manufacturer CountryUS
Manufacturer Postal49544
Manufacturer Phone6162598350
Manufacturer G1VENTLAB LLC.
Manufacturer Street2710 NORTHRIDGEDR. SUITE A
Manufacturer CityGRAND RAPIDS MI 49544
Manufacturer CountryUS
Manufacturer Postal Code49544
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHYPERINFLATION SYSTEM
Generic NameHYPERINFLATION BAG
Product CodeNHK
Date Received2016-06-22
Catalog NumberHS34051
Lot Number304597
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerVENTLAB LLC.
Manufacturer Address2710 NORTHRIDGEDR. SUITE A GRAND RAPIDS MI 49544 US 49544


Patients

Patient NumberTreatmentOutcomeDate
10 2016-06-22

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