MAUDE MDR 3660742

MDR report key
3660742
Report number
MW5034786
Event key
0
Event type
3
Date of event
2014-01-08
Date received
2014-02-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CPAP OSCPAP OSEMERGENT RESPIRATORY PRODUCTSBYECPAP OSCE8341

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-02-270

Event Narratives#

D

Patient 1

CPAP TOOK APPROXIMATELY ONE MINUTE TO INITIATE AIRFLOW UPON SET UP OF DEVICE AND INITIATION OF O2.