FDA.reportPublic FDA data

MAUDE MDR 2495937

MDR report key
2495937
Report number
MW5024668
Event key
0
Event type
3
Date of event
2012-03-13
Date received
2012-03-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
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
1S8 VANTAGE AUTO CORECPAPRESMEDBYES8 VANTAGE AUTO CORE Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-03-1401. L; 2. O

Event Narratives#

D

Patient 1

THE CPAP I USE FOR MY SLEEP APNEA JUST SHUTS OFF WHILE IN USE. THE SUDDEN LACK OF AIR FLOW AND SUBSEQUENT DIFFICULTY WAKE ME UP. THIS HAPPENED TWO TIMES ON THE EVENING OF (B)(6) 2012. THIS HAS HAPPENED BEFORE MULTIPLE TIMES AND WHEN I CONTACT THE DME COMPANY THEY CANNOT OR WILL NOT HELP. THE LAST INCIDENT WAS (B)(6) 2012. I HAVE HAD AT LEAST TWO DIFFERENT NIGHTS WHEN THE MACHINE SHUT OFF MORE THAN 4 TIMES DURING THE NIGHT. AT FIRST I THOUGHT IT WAS A POWER PROBLEM (IE DIRTY POWER) BECAUSE IT SEEMED TO HAPPEN MOSTLY WHEN I WAS AWAY FROM HOME. IT IS ALWAYS PLUGGED INTO A SURGE PROTECTOR- BUT I BEGAN USING A SURGE PROTECTOR AWAY FROM HOME AND THE PROBLEM PERSISTED AND BEGAN HAPPENING AT HOME ALSO. THIS PROBLEM NOT ONLY DISRUPTS MY SLEEP BUT I WORRY THAT ONE DAY THE SUDDEN LACK OF AIR WILL NOT WAKE ME UP AND THIS DEVICE MALFUNCTION MAY CONTRIBUTE TO OR CAUSE SUFFOCATION.