FDA Adverse Event Malfunction Summary report: N

OEM NIBP BOARDS

MDR report key: 206829 · Received January 19, 1999

Report

Report Number
MW1015473
Event Type
Malfunction
Date Received
January 19, 1999
Report Date
January 14, 1999
Manufacturer
PACE TECH, INC.
Product Code
DXN
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
BR
Reporter Occupation
ATTORNEY

Narratives

Description of Event or Problem · 1

RPTR WRITES TO MFR, "WE WILL BE SENDING TO YOU A PUMP FROM ONE NIBP KIT OF YOUR LAST SHIPMENT. THIS PUMP SHOWED A PROBLEM WHEN TESTED WITH THE DYNATECH SIMULATOR. WE TRIED WITH ANOTHER PUMP TO MAKE SURE THAT THE PROBLEM WAS IN IT. PLEASE WE WOULD LIKE TO RECEIVE A REPLACEMENT FOR THIS PUMP AS SOON AS POSSIBLE. ALSO WE WOULD LIKE TO RECEIVE YOUR BEST PRICE FOR ANOTHER TWO PUMPS THAT WILL BE USED AS REPLACEMENT PARTS FOR DEFECTIVE PUMPS THAT MAY SHOW IN FUTURE. WE ALSO HAVE TO CALIBRATE ALL THE KITS RECEIVED (WHAT TAKES ABOUT 40 MINS EACH). ALL THE KITS SHOWED CALIBRATION PROBLEMS ON THE OVER PRESSURE TEST (THEY WERE SET BETWEEN 290MMHG AND 310MMHG). ALSO WE HAVE TO CALIBRATE ALL THE VALVE KITS THAT SHOWED MAXIMUM VALUES ABOVE THE SPECIFIED ON THE PROCEDURES. THE PROCEDURE USED TO ANALYZE THE KITS WAS THE ONE SENT TO YOU. ALL THE KITS WERE THEN APPROVED USING A DYNATECH CUFF LINK NON INVASIVE PRESSURE SIMULATOR. ON THE NEXT SHIPMENT PLEASE VERIFY THE PROBLEMS DESCRIBED ABOVE." STAFF WRITES TO MFR, "I RECEIVED 3 EQUIPMENTS, WHICH WERE INTEGRATED WITH NIBP PACETECH BOARDS. ALL THE CUSTOMERS (3 DIFFERENT CUSTOMERS) SAID TO ME THAT THE VALUE MEASURED WAS WRONG (VERY HIGH OR VERY LOW). I WENT TO MY REPAIR/TEST ROOM, AND CHECKED THE EQUIPMENT. I MADE CURVES FOR EACH EQUIPMENT, AND AGAIN I AM SENDING THESE CURVES TO YOU, FOR YOUR EVALUATION. CURVE #1: I OBSERVED THAT THE VALUES ARE VERY DISPERSE (ATTENTION TO SYSTOLIC CURVE). FOR ME, THE NIBP BOARD IS ONLY OUT OF CALIBRATION. I NOTED ALSO A BIG DIFFERENCE BETWEEN THE TWO MEASURES. FOR THE NURSE THIS FACT CAN INTRODUCE A BAD INTERPRETATION OF PT STATUS. FOR YOUR INFO, THE CUSTOMER USES OUR EQUIPMENT IN A SURGERY ROOM, CURVE #2: I OBSERVED THAT VALUES ARE NOT VERY DISPERSE, LIKE AS CURVE #1, BUT I WOULD LIKE TO RECEIVE YOUR OPINION ABOUT THIS CURVE. FOR ME THE EQUIPMENT IS OPERATING PROPERLY, AND THE CUSTOMER IS WRONG. OUR CUSTOMER USES THIS EQUIPMENT IN HEMODIALYSIS ROOMS. THE CUFF IS POSITIONED IN PT LEG. IF YOU HAVE SOME SPECIAL RECOMMENDATION ABOUT THIS CUSTOMER PROCEDURE, PLEASE SEND ME. CURVE #3: I OBSERVED THAT THE VALUES ARE MUCH TO LOW. THE CHOICE PT FOR THE TEST WAS I. FREQUENTLY THE BOARDS SHOWED THE MESSAGE "LOOKING PULSE". IS RELATED WITH CALIBRATION? I HAVE TWO PROPOSALS: 1) I SENT THESE BOARDS (WITH ONLY TRANSDUCER) TO YOU, WHILE YOU SEND 3 NEW BOARDS FOR ME. 2) IF YOUR OPINION ABOUT THE 3 BOARDS IS RELATED TO A SINGLE RECALIBRATION, I AND ANOTHER STAFF MEMBER CAN RECALIBRATE THE BOARDS USING A CUFFLINK (IS A NIBP SIMULATOR FROM DYNATECH). I WAS INTRODUCING A CAPACITOR BETWEEN VCC PIN AND GROUND PIN OF 12887 MEMORY. I WAS ALSO INTRODUCING A WIRE BETWEEN GROUND PIN AND SUPPLY CONNECTOR EARTH PIN. I HOPE TO REDUCE ALL THE ELECTRICAL INTERFERENCE. THIS CASE IS UNDER OUR CONSIDERATION. I SENT TO YOU THREE BOARDS WITH PROBLEMS IN THE 12887 MEMORY FOR YOUR EVALUATION. IF YOU EXCHANGE THE MEMORY, THE BOARD IS GOOD. I VERIFY THIS. I NEED 10 (TEN) 12887 MEMORIES FOR REPAIR, BECAUSE MY RESERVE IS MEETING THE END."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 OEM NIBP BOARDS OEM NIBP BOARDS DXN PACE TECH, INC. NIBP OEM BOARDS *

Patients

Seq Age Sex Outcome Treatment
1 * Other