FDA.reportPublic FDA data

MAUDE MDR 8458950

MDR report key
8458950
Report number
8458950
Event key
0
Event type
3
Date of event
2019-01-29
Date received
2019-03-28
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
100
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
0UNKNOWNREGULATOR, PRESSURE, GAS CYLINDEROHMEDA MEDICALCAN* Y
1UNKNOWNREGULATOR, PRESSURE, GAS CYLINDEROHMEDA MEDICALCAN* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-280

Event Narratives#

D

Patient 1

OXYGEN WALL PORT LEAKING. MAINTENANCE TURNED OFF O2 AND WAS UNABLE TO FIX. PT WAS REQUIRING OXYGEN SO WAS MOVED TO ANOTHER ROOM. MOTHER WAS UNHAPPY REGARDING THE MOVE BUT WAS UNDERSTANDING. ROOM OUT OF SERVICE UNTIL REPAIR TAKES PLACE. NOTE: NO IDENTIFIERS ARE AVAILABLE FROM THE WALL PLATE ITSELF. MAINTENANCE HAD THE UNIT REPAIRED IN 24 HRS. MANY OF THE WALL PORTS ARE "WIGGLY", MAINLY DUE TO AGE OF THE UNIT AND THE INSTALLATION PROCESS UNABLE TO LOCATE SN, MODEL #, OR OTHER IDENTIFIER.