FDA.reportPublic FDA data

MAUDE MDR 6510141

MDR report key
6510141
Report number
3003477173-2017-00001
Event key
0
Event type
3
Date of event
2017-02-24
Date received
2017-04-20
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
MS DIANE HOWELL
Address
1905 COUNTY RD C WEST ROSEVILLE MN 55113 US
Phone
651-651-6514
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RESQPUMPRESQPUMPADVANCED CIRCULATORYPIZ12-0823-00050908708Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-200

Event Narratives#

N

Patient 1

THE PUMP ARRIVED PARTIALLY ASSEMBLED. THE M5 WASHER WASN'T INCLUDED IN THE RETURN HOWEVER THERE IS EVIDENCE THAT THERE HAD BEEN A WASHER INSTALLED PREVIOUSLY. WHEN OR HOW THE WASHER WAS SEPARATED FROM THE SYSTEM IS UNKNOWN. THE ON -SCENE SUPERVISOR REPORTED THAT THE PUMP HAD BEEN IN USE FOR OVER 30 MINUTES BEFORE THE FAILURE OCCURRED. IT IS EVIDENT THAT THE M5 SCREW WAS ENGAGED IN THE THREADS (FULLY SEATED OR NOT IS UNKNOWN) AND BACKED OUT DURING OPERATION. BRASS SHAVINGS WERE IN THE SCREW THREADS ALONG THE ENTIRE ENGAGEMENT DEPTH INDICATING THAT, AT LEAST AT ONE TIME, THE SCREW WAS FULLY ENGAGED. THE THREADS WERE FAIRLY LOOSE BUT NOT COMPLETELY STRIPPED. THE CLAMSHELL/STEM KEY FEATURE, WHICH ALIGNS THE TWO, SHOWED SIGNS OF DAMAGE AT THE TOP. INFORMATION ON CALIBRATION/MAINTENANCE EVENTS ON THIS DEVICE HAS BEEN REQUESTED AS THE SCREW IN QUESTION IS REMOVED DURING CALIBRATION. THE IFU PROVIDES THE RE-CALIBRATION INSTRUCTIONS FOR THE USER TO RE-ZERO THE FORCE GAUGE. THIS INCLUDES REMOVING THE SUCTION CUP, LOOSENING THE SCREW AND REASSEMBLING THE DEVICE. THERE IS EVIDENCE OF CALIBRATION AS THE ADJUSTMENT SCREW HEAD IS PARTIALLY STRIPPED. THE USER HAS NOT CONFIRMED ANY MAINTENANCE PERFORMED. IN SUMMARY, THE PROBLEM WITH THE DEVICE WAS THE UNINTENTIONAL SEPARATION OF THE STEM/SUCTION CUP ASSEMBLY FROM THE REST OF THE DEVICE DUE TO A PROBLEM DURING OPERATIONAL PERFORMANCE. WITHOUT BEING ABLE TO RE-CREATE THE FAILURE AND/OR FURTHER INFORMATION WE ARE UNABLE TO CONFIRM THE COMPLAINT.

D

Patient 1

WHILE USING THE RESQPUMP TO PERFORM CPR ON A PATIENT ON THE FLOOR OF A RESIDENCE, THE RESCUE PUMP MALFUNCTIONED AND SEPARATED INTO TWO PIECES. THE SOFT PLASTIC PLUNGER SEPARATED FROM THE HARD PLASTIC BASE DURING THE UPWARD PORTION OF THE NORMAL COMPRESSION CYCLE. THE PUMP WAS POSITIONED APPROPRIATELY ON THE CHEST AND SEEMED TO BE WORKING FINE THROUGH SEVERAL CYCLES OF USE AND THROUGH MULTIPLE USERS UNTIL IT STARTED TO GET LOOSE AND FINALLY SEPARATE. WE WERE ABLE TO CONTINUE CPR AND RETRIEVE ANOTHER DEVICE TO CONTINUE THE RESUSCITATION EFFORT. A QUICK EXAMINATION OF THE DEVICE ON SCENE SHOWED THAT A MAIN CENTER SCREW IN THE DEVICE HAD BACKED OUT TO THE POINT OF DEVICE FAILURE.