FDA.reportPublic FDA data

MAUDE MDR 9897908

MDR report key
9897908
Report number
2518422-2020-00809
Event key
0
Event type
3
Date of event
2020-03-18
Date received
2020-03-30
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 DRIVE NEW KENSINGTON, PA US
Phone
334-334-3349
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRILOGY100VENTILATOR, CONTINUOUS, FACILITY USERESPIRONICS INCCBK10542601054260Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-300

Event Narratives#

D

Patient 1

THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO CHARGE ITS INTERNAL BATTERY AND A SERVICE REQUIRED ALARM CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICES INTERNAL BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE.