FDA.reportPublic FDA data

MAUDE MDR 881684

MDR report key
881684
Report number
MW5003051
Event key
0
Event type
3
Date of event
2007-07-11
Date received
2007-07-11
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
1RESMEDCPAP MACHINENANHJS7 ELITENY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-07-1101. O

Event Narratives#

D

Patient 1

I WENT TO THE OFFICES IN 2007 TO RETURN THEIR MEDICAL EQUIPMENT TO THEM. THEY ARE SUPPOSED TO BE THE EXPERTS IN DIAGNOSIS AND TREATMENT OF SLEEP APNEA. THE RESMED S7 ELITE CONTINUOUS POSITIVE AIRWAY PRESSURE -CPAP- MACHINE I WAS GIVEN TO TRY OUT FOR "RENTAL" IS NOT EFFECTIVE. IT WAS NOT TREATING MY CONDITION ANY. I KEPT TELLING THE PEOPLE AT THE CO THAT THEIR PRODUCT WAS NOT DOING ME ANY GOOD. IT WAS NOT HELPING MAKE MY SLEEP APNEA ANY BETTER. I WAS TOLD ON 07/11/07 THAT THEY WOULD NOT ACCEPT THEIR MEDICAL EQUIPMENT BACK FOR RETURN AND THAT I HAD TO KEEP THE MACHINE. I NEVER SIGNED A PURCHASE AGREEMENT WITH THEM TO PURCHASE THE MACHINE. WHY SHOULD I BE MADE TO KEEP SOMETHING I TOLD YOU DOES NOT WORK PROPERLY AND DOES NOT HELP TREAT MY MEDICAL CONDITION? DATES OF USE:2006 -2007. DIAGNOSIS OR REASON FOR USE: MILD SLEEP APNEA. EVENT ABATED AFTER USE: YES.