FDA.reportPublic FDA data

MAUDE MDR 6499859

MDR report key
6499859
Report number
MW5069143
Event key
0
Event type
3
Date of event
2017-04-12
Date received
2017-04-14
Adverse event
3
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
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MORTARATREADMILLMORTARA INSTRUMENTS, INC.IOLTMX58110I Y
2MORTARATREADMILLMORTARA INSTRUMENTS, INC.IOLTMX58110I Y
3MORTARATREADMILLMORTARA INSTRUMENTS, INC.IOLTMX58110I Y
4MORTARATREADMILLMORTARA INSTRUMENTS, INC.IOLTMX58110I Y
5MORTARATREADMILLMORTARA INSTRUMENTS, INC.IOLTMX58110I Y
6MORTARATREADMILLMORTARA INSTRUMENTS, INC.IOLTMX58110I Y
7MORTARATREADMILLMORTARA INSTRUMENTS, INC.IOLTMX58110I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-140

Event Narratives#

D

Patient 1

NEW MORTARA TREADMILLS STOP SPONTANEOUSLY POSING A HAZARD TO CARDIOPULMONARY REHAB PATIENTS. MORTARA REP NOTIFIED AND STAFF CAME TO INVESTIGATE AND TREADMILLS PUT BACK IN SERVICE. PROBLEM PERSISTS DESPITE MORTARA LOOKING INTO THE MATTER. WE ARE CONCERNED ABOUT THE POTENTIAL HAZARD OF OUR BRAND NEW TREADMILLS STOPPING SPONTANEOUSLY.