FDA.reportPublic FDA data

MAUDE MDR 9868183

MDR report key
9868183
Report number
3012307300-2020-02194
Event key
0
Event type
3
Date of event
2020-02-24
Date received
2020-03-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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 VR1 AIR MIXVENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)SMITHS MEDICAL ASD,INC.BTLVR1AIRNSEY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-230

Event Narratives#

N

Patient 1

INVESTIGATION RESULTS COMPLETED ON A SMITHS MEDICAL PNEUPAC VENTILATORS VR1 AIR MIX . REPORTED A VIDEO WAS ATTACHED TO REVEAL SHOW WHAT WAS ISSUE BUT IT WAS VIDEO UPSIDE DOWN, SO THEREFORE UNABLE TO WATCH. THE DEVICE WAS USED AS A DEMO AND UPON VISUAL INSPECTION, THIS REVEALED CRACKED IN LOWER CASE ADN HILE IN THE MOMENTARY CONTROL RUBBER. THIS IS BELIEVED TO BE CAUSED BY WEAR AND TEAR OF OFTEN USAGE . DEVICE WAS TESTED AND MULTIPLE ISSUES FOUND WITH FAULT FOUND DO TO DAMAGE. THE ENGINEER CONCLUSION: AS THIS WAS A DEMO UNIT, IT IS SUGGESTED THAT THE NUMBER OF LEVER OPERATIONS MUST HAVE EXCEEDED THE NUMBER SET OUT IN THE REQUIREMENTS SPECIFICATION FOR THIS DEVICE. CONSEQUENTLY, THIS LED TO UNCHARACTERISTIC WEAR OF THE MATING COMPONENTS AND BUILD-UP OF DEBRIS WHICH ULTIMATELY LED TO THE LEAK AND FAILURE MODE OF CONSTANT . ACTION WAS TAKEN TO REPLACE DAMAGE PARTS.

D

Patient 1

?INFORMATION RECEIVED A SMITHS MEDICAL PNEUPAC VENTILATORS VR1 AIR MIX TESTING WAS BEING DONE AND THE VR 1 DID NOT BREAK THE BREATH AND KEPT BLOWING. THIS OCCURRED THREE TIMES. EVENT WAS DURING TESTING AND NO PATIENT INVOLVEMENT.