FDA.reportPublic FDA data

MAUDE MDR 7568825

MDR report key
7568825
Report number
MW5077631
Event key
0
Event type
3
Date of event
2018-05-21
Date received
2018-06-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WATCH PAT 200VENTILATORY EFFORT RECORDERITAMAR MEDICAL INC.MNRWATCH PAT 200I N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-040

Event Narratives#

D

Patient 1

I USED THE WATCH PAT 200 FOR MY SLEEP APNEA AND I DON'T THINK THE DEVICE IS FUNCTIONING RIGHT. I DON'T THINK THEY ARE CALIBRATING THE DEVICE RIGHT IN THEIR OFFICE FOR REPAIR. DATE OF USE: 8 HOURS. DIAGNOSIS OR REASON FOR USE: SLEEP ISSUE.