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MAUDE MDR 6033987

MDR report key
6033987
Report number
6033987
Event key
0
Event type
3
Date of event
2016-09-22
Date received
2016-10-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1ALICE NIGHTONESLEEP STUDY MONITORPHILIPS RESPIRONICSMNR113277UNKNAI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-0501. O

Event Narratives#

D

Patient 1

PATIENT REPORTED THAT SHE SUSTAINED A BURN TO HER CHEST FROM AN ALICE NIGHTONE MONITOR FOR AN AT HOME SLEEP STUDY. THE EVENT TOOK PLACE ON (B)(6) 2016 AT THE PATIENT'S HOME. THE PATIENT REPORTED THAT SHE WAS GIVEN THE DEVICE TO USE DURING A AT HOME SLEEP STUDY. THE DEVICE IS CALLED AN ALICE NIGHTONE AND IS MANUFACTURED BY PHILIPS. THE PATIENT CLAIMS THAT THE DEVICE SPARKED AT SOME POINT. THE PATIENT STATED THAT SHE WENT TO SLEEP AND WHEN SHE WOKE UP SHE HAD A BURN UNDERNEATH THE DEVICE. THE BURN IS DESCRIBED AS A 2X2 CENTIMETER CIRCULAR BURN LOCATED ON THE RIGHT CENTER OF THE PATIENT'S CHEST. THE BURN IS FULL THICKNESS.