FDA.reportPublic FDA data

MAUDE MDR 3171893

MDR report key
3171893
Report number
3171893
Event key
0
Event type
3
Date of event
2013-02-16
Date received
2013-05-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIPAP VISIONATTACHMENT, BREATHING, POSITIVE AND EXPIRATORYRESPIRONICS, INC.BYE582059** Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-05-290

Event Narratives#

D

Patient 1

ATTEMPTED TO CHANGE THE MODE ON THE BIPAP ALREADY IN USE BY THE PATIENT. THE MACHINE WOULD NOT ALLOW THE CHANGE TO BE MADE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PATIENT WAS ALREADY IN DISTRESS AND THE PRACTITONER ATTEMPTED TO CHANGE THE MODE ON THE BIPAP MACHINE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.