FDA.reportPublic FDA data

MAUDE MDR 9903061

MDR report key
9903061
Report number
2518422-2020-00772
Event key
0
Event type
3
Date of event
2020-03-12
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. ADAM PRICE
Address
312 ALVIN DR NEW KENSINGTON, PA US
Phone
334-334-3349
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRILOGY 100VENTILATOR, CONTINUOUS, FACILITY USERESPIRONICS, INC.CBK10546551054655Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

D

Patient 1

A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.