VENTLAB PEEP VALVE SS3100MB-P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-16 for VENTLAB PEEP VALVE SS3100MB-P manufactured by Venlab.

Event Text Entries

[28865004] Product would not hold peep pressure when tested on test lung.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2246980-2015-00020
MDR Report Key5156964
Date Received2015-10-16
Date of Report2015-10-16
Date of Event2015-09-29
Date Mfgr Received2015-09-29
Date Added to Maude2015-10-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRESPIRATORY THERAPIST
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 Phone6162598400
Manufacturer G1VENLAB
Manufacturer Street2710 NORTHRIDGE DR. SUITE A
Manufacturer CityGRAND RAPIDS 49544
Manufacturer CountryUS
Manufacturer Postal Code49544
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVENTLAB PEEP VALVE
Generic NamePEEP VALVE
Product CodeBYE
Date Received2015-10-16
Returned To Mfg2015-10-09
Model NumberSS3100MB-P
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerVENLAB
Manufacturer Address2710 NORTHRIDGE DR. SUITE A GRAND RAPIDS MI 49544 US 49544


Patients

Patient NumberTreatmentOutcomeDate
10 2015-10-16

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