BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL DATA ELECTRONICS ESCORT PRISM

    MDR report key: 394707 · Received May 9, 2002

    Report

    Report Number
    MW1025013
    Event Type
    Malfunction
    Date Received
    May 9, 2002
    Date of Event
    December 1, 2000
    Report Date
    May 9, 2002
    Manufacturer
    MDE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 2-4-03: ALL AFFECTED DEVICES HAVE RECEIVED AN UPGRADE TO CONTROL THE INTERNAL TEMPERATURE OF THE DEVICE. THERE HAVE BEEN NO REPORTS OF OVERTEMPERATURE SINCE THESE DEVICES WERE REPAIRED.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/8/02: COMPLETE DESCRIPTION: SERIAL NUMBERS SENT TO MEDICAL DATA ELECTRONICS (MDE) FOR FACTORY REPAIR. NONE OF THE COMPLAINTS REPORTED BY THE USER WERE DESCRIBED AS BEING PART OF AN INCIDENT OR EVEN NEAR INCIDENT. RECENT MDR SENT TO THE FDA APPEARS TO BE RELATED TO FRUSTRATION BY END USER REGARDING MDE PRODUCT RELIABILITY. ANALYSIS FINAL RESULTS: SOFTWARE VALIDATION AND CONTROL DEPT INVESTIGATED COMPLAINT (FROM MDE FINAL TEST DEPT) REGARDING TEMP ALARM LIMIT SETTINGS (DEGREES C VS F) IN DEEP CONFIGURATION. THE SAME MODEL WITH THE SAME VERSION SOFTWARE WAS EVALUATED FOR FUNCTIONALITY AND PERFORMANCE REGARDING THIS ISSUE. THERE WAS NO FAILURE MODE IDENTIFIED DURING THIS INVESTIGATION, AS THE DEEP CONFIGURATION SETTING HAD NO EFFECT ON THE PERFORMANCE OF THE SURETEMP PARAMETER. WHEN SURETEMP OPTION IS AVAILABLE, THERE IS AN ALARM LIMIT SETTING ONLY IN THE DEEP CONFIGURATION PAGE OF TEMP1. THE SURETEMP DOES NOT SUPPORT SETTING OF ALARM LIMITS, SO THIS HAD NO EFFECT ON ALARMS OR LIMITS OF ALARMS FOR THIS PARAMETER. ALSO, IF THE UNIT OF MEASUREMENT IS SELECTED FOR ONE SETTING (F OR C), THE ALARM LIMITS IN THE DEEP CONFIGURATION PAGE SHOWS DIFFERENT UNIT OF MEASUREMENT. CONCLUSION: THIS LABEL FOR UNIT OF MEASUREMENT IS FOUND IN THE DEEP CONFIGURATION PAGE. DEEP CONFIGURATION PAGES ARE NOT VISIBLE DURING NORMAL USE OF THE PRODUCT, AND THEREFORE THIS DISCREPANCY COULD NOT CAUSE CONFUSION AMONG USERS. ALARM MONITORING, DELIVERY OF ENERGY, AND REAL TIME PT DATA ARE NOT AFFECTED BY THIS ISSUE. PRISM MONITORS WERE CLEARED TO SHIP WITH RESPECT TO THIS ISSUE. THE SOFTWARE PERFORMANCE REPORT WAS DOCUMENTED AND FILED FOR POSSIBLE FUTURE SOFTWARE DEVELOPMENT. MODEL 20413 FIRST SERIAL NUMBER: CUSTOMER REPORTED SPO2 AND TEMP NOT WORKING DUE TO THE HEAT INSIDE CHASSIS OF MONITOR. CUSTOMER ORDERED A BOARD EXCHANGE FROM MDE ON 8/29/01 FOR BEDSIDE MONITOR (SPO2 BOARD). CUSTOMER INSTALLED NEW BOARD AND FOUND SAME ERROR MESSAGE ON SCREEN (02 ROM ERROR). CUSTOMER ORDERED REPLACEMENT BOARD AND FOUND SAME RESULT ON 9/11/01. CUSTOMER REQUESTED FACTORY REPAIR OF BEDSIDE MONITOR TO RESOLVE THIS PROBLEM ON 9/21/01. CONCLUSION: UNIT WAS UPDATED WITH NEW POWER SUPPLY, TESTED ALL FUNCTIONS TO MFR SPECS AND REPLACED MEMBRANE SWITCH PANEL. NO TEMP RELATED FAILURE REPRODUCED DURING EVALUATION. UNIT SHIPPED BACK TO CUSTOMER 9/28/01. 4/1/02: MDE CONTACTED CUSTOMER TO DISCUSS REPORT OF SURETEMP PROBLEMS THEY HAD BEEN EXPERIENCING WITH THEIR EQUIPMENT. CUSTOMER DESCRIBED ISSUE AND STATED THAT THIS DEVICE WAS ALSO MAKING A CLICKING NOISE. THE DEVICE WAS RETURNED TO MDE FOR UPGRADE TO FAN ASSEMBLY AND EVALUATION FOR CLICKING NOISE. CONCLUSION: TBD. STATUS OF DEVICE: DEVICE IS CURRENTLY AT MDE FOR UPGRADE AND EVALUATION. MODEL 20413 THIRD SERIAL NUMBER: 2/15/02 MDE NOTIFIED OF MONITOR RESETTING. HOSP BIO-MED HAD NOT BEEN ABLE TO DUPLICATE NURSE COMPLAINT OF RESETS. SENT IN FOR FACTORY REPAIR AT MDE. UNABLE TO VERIFY RESET FAILURE. PERFORMED ENGINEERING CHANGES TO UNIT AS PREVENTATIVE MEASURE. ALL FUNCTIONS TESTED TO MFR SPECS. CONCLUSION: DEVICE WAS TESTED BOTH BY FACTORY REPAIR TECH AND ENGINEERING DEPT INCLUDING USING "HOT BOX" TO REPRODUCE CUSTOMER COMPLAINT WITHOUT SUCCESS. UNABLE TO VERIFY SYMPTOM DESCRIBED BY CUSTOMER. CONTINUED TO LOOK FOR ANY TRENDS/REPEAT FAILURE OF THIS DEVICE. STATUS OF DEVICE: UPDATED UNIT AND RETURNED TO USER FACILITY. MODEL 20413 NINTH SERIAL NUMBER: 2/8/01 MDE NOTIFIED OF SPO2 PARAMETER NOT WORKING. DEVICE RETURNED TO MFR ON 2/13/01. EVALUATION OF UNIT REVEALED MASSIMO SPO2 BOARD MALFUNCTION, CAUSING THE WAVEFORM AND SPO2 VALUES NOT TO BE DISPLAYED ON THE SCREEN. CONCLUSION: MASIMO BOARD WAS REPLACED AND DEVICE QUALITY TESTED AND PASSED FINAL QA TESTING AS WELL. 8/3/01 CUSTOMER COMPLAINED THAT SURETEMP PARAMETER WOULD NOT CHANGE MODES (RECTAL TO ORAL). SENT IN TO MDE FOR FACTORY REPAIR ON 8/13/02. MDE VERIFIED CUSTOMER COMPLAINT, FOUND CONNECTOR TO SURETEMP PCBA NOT SEATED PROPERLY. MDE UPGRADED FAN ASSEMBLY AS PART OF PREVENTATIVE MEASURE. CONCLUSION: THE CONNECTOR ASSEMBLY COULD NOT HAVE BEEN PARTIALLY CONNECTED WHEN THE UNIT SHIPPED BACK TO THE CUSTOMER ON THE ORIGINAL REPAIR (UNIT WOULD NOT HAVE PASSED QA TEST). THE UNIT SHIPPED BACK TO CUSTOMER ON 3/27/01 AND THIS COMPLAINT WAS REPORTED ON 8/3/01. IT IS POSSIBLE THAT THE CONNECTOR WAS NOT SEATED COMPLETELY DURING THE INITIAL REPAIR AND OVER TIME BECAME LOOSE. THE FAILURE MODE DESCRIBED IN THIS COMPLAINT WAS NOT RELATED TO HEAT. STATUS OF DEVICE: THIS DEVICE HAS BEEN UPDATED WITH THE MODIFICATION TO THE FAN ASSEMBLY, QUALITY TESTED AND RETURNED TO THE CUSTOMER. MODEL 20413 TENTH SERIAL NUMBER: 5/7/02 MDE NOTIFIED OF MONITOR HAVING INTERMITTENT SPO2. CUSTOMER REQUESTED WARRANTY FACTORY REPAIR SINCE MDE COULD DO UPGRADES WHILE IT WAS IN BEING REPAIRED. DEVICE WAS EVALUATED FOR ANY HEAT RELATED SPO2 PERFORMANCE PROBLEMS. QA ENGINEER FORCED INTERNAL TEMP OF MONITOR TO 120 DEGREES F AND FOUND THE SPO2 STILL WORKED PER SPECS. MDE INFORMED CUSTOMER OF THIS AND THE CUSTOMER THEN STATED IT WAS AN INTERMITTENT PROBLEM WITH ECG. MDE RAN THE UNIT OVERNIGHT AND DID FIND INTERMITTENT PROBLEM WITH ECG. QA MGR AUTHORIZED REPLACEMENT OF CPU BOARD WITH NEW AT NO CHARGE TO SATISFY CUSTOMER. CONCLUSION: THIS DEVICE DID NOT HAVE TEMP RELATED PROBLEM AS INDICATED BY CUSTOMER. SPO2 AND SURETEMP WORKED CORRECTLY. ECG FAILURE ON CPU IDENTIFIED AND CPU BOARD REPLACED WITH NEW. STATUS OF DEVICE: DEVICE HAS BEEN UPDATED WITH LATEST MODIFICATION FOR FAN ASSEMBLY & RETURNED TO CUSTOMER AFTER PASSING ALL QUALITY TESTS. MODEL 20011V ELEVENTH SERIAL NUMBER: 6/7/01 MDE NOTIFIED OF DEVICE NOT COMMUNICATING WITH CENTRAL STATION. MDE VERIFIED COMPLAINT, RE-TUNED RF RADIO, QUALITY TESTED AND RETURNED TO CUSTOMER. CONCLUSION: THIS DEVICE REQUIRED RE-TUNING (ADJUSTMENT OF RF TRANSMITTER POWER). NO COMPONENTS WERE FOUND TO BE DEFECTIVE. 10/5/01 MDE NOTIFIED THAT DEVICE HAD "BURNING SMELL". RETURNED UNIT TO MDE FACTORY ON 10/8/01 FOR EVALUATION. CONTINUED IN B6.

    Description of Event or Problem · 1

    DATES OF EVENTS ARE MULTIPLE. MDE ESCORT PRISM, MODEL 20413, THEN EACH EQUIPPED WITH MASIMO SPO2, WELCH ALLYN SURETEMP, NIBP, TWO TEMP CAPABILITY, ETCO2, AND ECG. UNITS PLACED INTO SVC 12/00. 1. TEMP CONFIGURE SOFTWARE OF ORIGINAL UNITS DISPLAY HIGH AND LOW TEMP PARAMETERS IN UNITS REVERSED FROM UNITS DIPLAYED, I.E. IF YOU CHOOSE READOUT IN DEGREES C THE HIGH AND LOW LIMITS ARE 100.4 AND 96.8 RESPECTIVELY OR JUST A LITTLE OVER BOILING AND A LITTLE UNDER. MONITORS LOSE FUNCTIONS DUE TO INTERNAL HEAT. THIS RPTR DETERMINED AND THE MDE FACTORY TECH SUPPORT AND SALESMAN VERIFIED. RPTR HAS DOCUMENTED WORK ORDERS REGARDING THIS. BOTH THE TECH AND SALESMAN SAID THEY WOULD ARRANGE TO GET THE UNITS BACK FOR FACTORY UPGRADE BUT NOTHING HAS OCCURRED YET. NOTE: SEVERAL OF THE UNITS RETURNED FOR REPAIR HAVE HAD "FAN UPGRADES TO ALLEVIATE THE TEMP PROBLEMS". HOWEVER, THEY HAVE FAILED WHILE IN USE AGAIN AND BEEN RETURNED TO MDE FOR REPAIR. HEAT PROBLEMS HAVE CAUSED ONE QUIT WORKING TWICE NECESSITATING A TRIP TO FACTORY FOR REPAIR 10/01. UNIT FAILED AGAIN (WELCH ALLYN AND MASSIMO). THE FIRST TEMP FAILURE REPAIRED BY FACTORY WAS 03/01. UNIT WAS SENT TO FACTORY FOR REPAIR. SECOND DEVICE'S SPO2 FAILED AND AGAIN MDE SALESMAN HAS STATED IT IS NOT A THERMAL PROBLEM WITH MDE IT IS A PROBLEM WITH THE MASSIMO PCB. SPOKE WITH MASSIMO ENGINEER. INTERFACE WITH MDE AND SHE STATED THAT MDE HAS ALWAYS BEEN HOT INSIDE, RUNNING ABOUT 68 DEGREES C AND THE MASSIMO HAS BEEN RATED AT ONLY 70 DEGREES C. SHE AND MDE WISH TO SEE THIS UNIT. THIRD DEVICE TRANSPONDER STARTED TO BURN IN CAT SCAN. SENT TO MDE FOR REPAIR. SHORTLY AFTER THE MONITOR BEGAN RESETTING ITSELF FOR NO REASON, SENT TO MDE. FOURTH DEVICE MONITOR, SPO2 FAILED AND FACTORY REPAIRED 10/01, 3/02. ALSO REPAIRED BROKEN WIRE INSIDE UNIT 12/01. MDE TECH 3/02 SAID THE SYMPTOMS REQUIRED FACTORY REPAIR, (FAN ALWAYS ON, CLICKING SOUND FROM INSIDE, SPO2 WAVEFORM PROBLEMS). THE DESIGNED AND SOLD FUNCTIONS ARE NOT ALL PRESENT ALL THE TIME, AS WOULD BE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL DATA ELECTRONICS ESCORT PRISM VITAL SIGNS MONITOR MHX MDE 20413 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other