FDA.reportPublic FDA data

MAUDE MDR 6955343

MDR report key
6955343
Report number
3003477173-2017-00007
Event key
0
Event type
3
Date of event
2017-09-02
Date received
2017-10-17
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
MRS DIANE HOWELL
Address
1905 COUNTY ROAD 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
1RESQPUMPRESQPUMPPIZY *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-170

Event Narratives#

N

Patient 1

THE PUMP ARRIVED WITH NO APPARENT EVIDENCE OF MODIFICATION OR MISUSE OF THE DEVICE. BRASS SHAVINGS WERE EVIDENT INSIDE THE CONNECTOR STEM AND ALONG THE M5 SCREW THREADS. THE CONNECTOR STEM HAD SOME SCRATCHES AT THE BOTTOM WHERE IT CONNECTS TO THE LOWER CLAMSHELL. THERE WAS ALSO SOME WEAR ON THE FACE OF THE ANCHOR LOWER NUT. THIS WEAR IS NOT NORMALLY OBSERVED IN USED DEVICES AND PRESUMABLY OCCURRED DURING SEPARATION. THE WASHER WAS BENT CONSIDERABLY BUT IT IS UNKNOWN WHEN THIS OCCURRED. WHEN THE STEM WAS REASSEMBLED WITH THE BENT WASHER THE STEM WASN'T ABLE TO BE FULLY SEATED. THIS RESULTED IN THAT ASSEMBLY BEING VERY LOOSE WHICH WOULD RESULTS IN A FAIR AMOUNT OF UNINTENDED MOVEMENT IN THE SYSTEM DURING USE. THERE WAS SOME WEAR AT THE END OF THE M5 SCREW INDICATING THAT, AT LEAST AT ONE TIME, THE SCREW WAS FULLY ENGAGED. INFORMATION ON CALIBRATION/MAINTENANCE EVENTS ON THIS DEVICE IS UNKNOWN THERE IS LITTLE EVIDENCE IF ANY OF CALIBRATION AS THE ADJUSTMENT SCREW IS IN GOOD CONDITION. 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

DURING PATIENT USE ON (B)(6), THE PLUNGER SEPARATED FROM THE HANDLE. THE CUSTOMER REVERTED TO MANUAL CPR UNTIL A REPLACEMENT ARRIVED ON SCENE. PATIENT WAS A (B)(6) YEAR OLD FEMALE. NO ADVERSE EFFECTS REPORTED.