FDA.reportPublic FDA data

MAUDE MDR 9887054

MDR report key
9887054
Report number
3012307300-2020-02257
Event key
0
Event type
3
Date received
2020-03-26
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#

Contact
DAVE HALVERSON
Address
6000 LANE N MINNEAPOLIS, MN US
Phone
383-383-3833
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VENTILATORS PNEUPAC VENTILATORS PARAPACVENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)SMITHS MEDICAL ASD,INCBTLVENTILATOR MEDIC PARAPAC510A1956NUSY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-260

Event Narratives#

N

Patient 1

?INVESTIGATION RESULTS COMPLETED ON A SMITHS MEDICAL VENTILATOR. THE COMPLAINT OF HEARING NOISE FOR BLOCKAGE AND POSSIBLE HIGH PRESSURE WAS NOT VALIDATED. WHEN EVALUATION AND TESTING WAS DONE TO DUPLICATE EVENT, THIS COULD NOT BE VERIFIED. AS PREVENTATIVE MEASURES , THE FLOW BLOCK ASSEMBLY WILL BE REPLACED. UNKNOWN WHAT WAS CAUSE OF EVENT. DEVICE ARRIVED IN GOOD CONDITION. AFTER PREVENTATIVE REPAIRS, THE DEVICE PASSED ALL TESTING. ?

D

Patient 1

INFORMATION RECEIVED A SMITHS MEDICAL VENTILATORS