FDA.reportPublic FDA data

MAUDE MDR 9908320

MDR report key
9908320
Report number
3012307300-2020-02643
Event key
0
Event type
3
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DAVE HALVERSON
Address
6000 NATHAN 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
1PNEUPAC? PARAPAC? VENTILATORVENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)SMITHS MEDICAL ASD; INC.BTL120003120003N R

Patients#

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

Event Narratives#

D

Patient 1

INFORMATION WAS RECEIVED INDICATING THAT THE BATTERY TO A SMITHS MEDICAL PNEUPAC? PARAPAC? VENTILATOR WAS BROKEN OFF ON THE SIDE. IT WAS REPORTED TO BE NOT GIVING LOW PRESSURE ALARMS. THE UNIT WAS ALSO DUE FOR PREVENTATIVE MAINTENANCE AND CALIBRATION. THERE WERE NO REPORTED ADVERSE EFFECTS.