FDA.reportPublic FDA data

MAUDE MDR 4039912

MDR report key
4039912
Report number
3007573469-2014-00008
Event key
0
Event type
3
Date of event
2014-06-10
Date received
2014-08-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
9001 SPECTRUM CENTER BOULEVARD -- SAN DIEGO CA 92123 US
Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GECKO NASAL PAD LGE - ROWRESMED LTDFMP6191361913E10L09201382* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-08-1301. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A DISORIENTED PT SUFFERING FROM RESPIRATORY FAILURE WAS CONNECTED TO A PHILIPS RESPIRONICS V60 RESPIRATOR. A TRANSPARENT SILICONE NASAL PAD WAS USED WITH THE MASK. THE NASAL PAD HAD SLIPPED AWAY FROM ITS POSITION UNDER THE MASK. IT WAS IN THE PT'S MOUTH, ON TOP OF THE TONGUE. IT COULD BE SEEN BETWEEN THE LIPS AND IT WAS MAKING BREATHING MORE DIFFICULT. THE TIDAL VOLUMES OF THE PT WERE DECREASED BY 50%, BREATHING FREQUENCY INCREASED FURTHER AND SATURATION WENT DOWN. THE TIDAL VOLUMES NORMALIZED AS SOON AS THE NASAL PAD WAS REMOVED FROM THE PT'S MOUTH. BECAUSE OF THE PT'S ILLNESS, INTUBATION WAS NECESSARY SHORTLY AFTER THE INCIDENT.