BD Intelliport 516704Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00382905167041), received between Feb 5, 2021 and May 26, 2022 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2022Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE BD INTELLIPORT¿ TABLET KIT FAILED TO TRANSFER THE NEWEST PATIENT DATA BETWEEN CARE AREAS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "USER NOTIFIED THAT THE INTELLIPORT TABLET IS NOT SHOWING THE NEWEST PATIENT THAT WAS SENT BY EPIC. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14503579 ↗
• MalfunctionMay 13, 2022Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT THE BD INTELLIPORT¿ TABLET KIT RECORDED A DUPLICATE DOSAGE WHEN THE SYRINGE WAS LEFT ATTACHED FOR 60 SECONDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT USER NOTIFIED THAT THE "WEIRD FINDING - LEFT SYRINGE ATTACHED FOR 60 SECONDS - AND IT CAME UP WITH DUPLICATE 60MG ENTRY" ON INTELLIPORT TABLET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401371 ↗
• MalfunctionJun 27, 2021Incorrect Measurement; Wireless Communication Problem; Incorrect Measurement; Wireless Communication Problem

  IT WAS REPORTED THAT THE KIT TABLET MEASURED THE AMOUNT OF PROPOFOL INCORRECTLY, AND DID NOT RECORD THE VECURONIUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DEVICE MEASURED THE AMOUNT OF PROPOFOL WRONG AND DIDN'T MEASURE THE VECURONIUM AT ALL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12073077 ↗
• MalfunctionJun 24, 2021Break; Break

  IT WAS REPORTED THAT THE KIT TABLET BASE FAILED, SHOWING A "WAITING FOR THE CASE TO BEGIN" SCREEN DURING THE SURGERY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CRNA INFORMED ME THAT IPAD WAS NOT WORKING. WHEN I GOT TO THE OR THE SCREEN WAS SHOWING ¿WAITING FOR THE CASE TO BEGIN¿ EVEN THOUGH THE CASE WAS IN THE MIDDLE OF THE SURGERY. THE CASE ENDED FOR CRNA WHEN PROCEDURE STARTED AFTER INDUCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12062945 ↗
• MalfunctionMay 14, 2021Break; Break

  IT WAS REPORTED THAT KIT TABLET SCREEN WENT BLANK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, BATCH, NO. 20028T02. IT IS REPORTED CUSTOMER WITNESSED SCREEN GO BLANK. VERBIAGE RECEIVED, - "FROM COMPLAINT SECTION IN AN INTELLIPORT PHASE III SURVEY: DATE: (B)(6) 2021, CASE 219, CART-1. "SCREEN WENT BLACK DURING CASE. COULD NOT RESOLVE ON MY OWN. TABLET FULLY CHARGED. NEEDED ASSISTANCE FROM STUDY COORDINATOR".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829549 ↗
• MalfunctionMay 14, 2021Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT KIT TABLET HAD RECORDING ISSUES. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, BATCH NO. 20028T02. IT IS REPORTED CUSTOMER PERFORMANCE ISSUES WITH RECORDING DRUGS AND VOLUMES. VERBIAGE RECEIVED, - "1. DATE: (B)(6) 2021, CASE 218, CART-1, SENSOR 9404. FROM COMMENT SECTION IN AN INTELLIPORT PHASE III SURVEY: "LIDOCAINE DID NOT DETECT FOR UNCLEAR REASON. 08:36 LIDOCAINE 60 MG (3 ML) BUT REGISTERED "VOLUME NOT MEASURED. DOSE GIVEN?" - USER INPUT 3 ML (60 MG) AT 8:38." "2. DATE: (B)(6) 2021, CASE 219, CART-1 SENSOR 9502. FROM COMMENT SECTION IN AN INTELLIPORT PHASE III SURVEY: "PROPOFOL DOSE NOT MEASURED FOR UNCLEAR REASON". 11:51 PROPOFOL 50 MG (5.0 ML) BUT REGISTERED "CONFIRM VOLUME AND DOSE" - USER INPUT 5 ML (50 MG) AT 11:52."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829443 ↗
• MalfunctionApr 28, 2021Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT KIT TABLET HAD INCORRECT DOSING REPORTED. THIS OCCURRED ON 4 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704 BATCH NO. 20028T02 IT WAS REPORTED THAT "MULTIPLE MEDICATION DOSES DIDN¿T MATCH WHAT WAS GIVEN ON TABLET". VERBIAGE- "MULTIPLE MEDICATION DOSES DIDN¿T MATCH WHAT WAS GIVEN ON TABLET".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742412 ↗
• MalfunctionApr 23, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT KIT TABLET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, BATCH NO. 20028T01 AND 20028T03. IT WAS REPORTED THAT TABLET HARDWARE AND CABLE WERE DAMAGED DURING USE. VERBIAGE- FROM COMPLAINT SECTION IN AN INTELLIPORT PHASE III SURVEY: DATE: MARCH 25, 2021, CART-2 AND CART-3. "CART 2 USB CABLE WAS DAMAGED IN THE OR. CRNA TEXTED ME THAT TABLET WAS AT 10% BATTERY AND THEN SHUT DOWN. I WENT TO THE OR AND THE USB CABLE WAS DAMAGED RIGHT WHEN IT CONNECTS TO THE TABLET. THE PORT IN THE TABLET IS FINE IT¿S JUST THE USB CABLE. I WAS ABLE TO GRAB ANOTHER CABLE AND TABLET IS CHARGING FINE. NO OTHER ISSUES WITH THE CASE ONCE IT WAS RESENT." "I NOTICED THAT OVER THE WEEKEND TABLET 3 JUST TURNED OFF. I TRIED CHARGING IT AND ALSO SWITCHED OUT THE CABLE FROM DIFFERENT TABLETS, BUT CART 3 TABLET STILL DID NOT TURN ON. I NOTICED THAT SPECIFIC POSITION OF THE CABLE STARTED CHARGING IT, BUT AS SOON AS I LET IT GO IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11719907 ↗
• MalfunctionApr 16, 2021Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT KIT TABLET HAD A SENSOR COMMUNICATION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704; BATCH NO. 20028T01. IT WAS REPORTED THAT THE SCREEN STATED ¿SENSOR #9702 NOT READY¿ IN RED AND THEN STATED ¿CONTINUE FLUSHING¿ IN YELLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682604 ↗
• MalfunctionApr 8, 2021Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT KIT TABLET HAD PERFORMANCE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, BATCH NO. 91DF1F51 AND 4FD8D2B8. IT IS REPORTED CUSTOMER EXPERIENCED PERFORMANCE ISSUES. VERBIAGE RECEIVED, - "FROM COMMENTS SECTION IN A POST MARKET SURVEY: DATE: MARCH 5, 2021, CASE 167, CART-3 3. "NOT AS ACCURATE WITH PICKING UP FENTANYL INJECTED. HAD TO GO BACK A FEW TIMES AND FILL IN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638968 ↗
• MalfunctionApr 8, 2021Failure to Read Input Signal; Failure to Read Input Signal

  MATERIAL NO. 516704, BATCH NO. 91DF1F51 AND 4FD8D2B8. IT IS REPORTED CUSTOMER EXPERIENCED PERFORMANCE ISSUES. VERBIAGE RECEIVED, - "FROM COMMENTS SECTION IN A POST MARKET SURVEY: DATE: MARCH 2, 2021, CASE 161, CART-2: 1. "ANCEF CONSISTENTLY STILL INACCURATE. I BELIEVE PROPOFOL TO BE VARIABLE BASED ON USER (VIAL IS OVERFILLED SO IF YOU DRAW UP ALL OF IT, IT TENDS TO BE 210MG IN THE SYRINGE). OTHERWISE NO ISSUES." 2. "OFTEN DOESN¿T REGISTER SUGAMMADEX DOSING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638967 ↗
• MalfunctionApr 8, 2021Failure to Transmit Record; Failure to Transmit Record

  IT WAS REPORTED THAT KIT TABLET DID NOT REGISTER THE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, BATCH NO. UNKNOWN. IT IS REPORTED CUSTOMER EXPERIENCED FUNCTIONAL ISSUES WHEN USING TABLET. VERBIAGE RECEIVED, - FROM COMPLAINT SECTION IN A POST MARKET SURVEY: 1. DECADRON FREQUENTLY DOES NOT REGISTER ON TABLET. 2. UNABLE TO CHANGE DOSE ON TABLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638945 ↗
• MalfunctionMar 26, 2021Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT KIT TABLET RECORDED THE INCORRECT DOSAGES. THIS OCCURRED ON 7 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, BATCH NO. 20028T03 IT IS REPORTED CUSTOMER EXPERIENCED THE RECORDING OF INCORRECT DOSAGES. VERBIAGE RECEIVED, - "CASE #156: TIME 10:20. SENSOR #9450 TABLET: CART-3 10:04 PROPOFOL 160 MG (16.0 ML) BUT REGISTERED 160 MG (16.5 ML) 10:05 VECURONIUM 7 MG (7 ML) BUT REGISTERED 6.5 MG (6.5 ML) 10:16 CEFAZOLIN 1000 MG (10 ML) BUT REGISTERED 900 MG (9 ML) 10:16 CEFAZOLIN 1000 MG (10 ML) BUT REGISTERED 950 MG (9.5 ML) CASE #(B)(4) TIME 13:00. SENSOR #9471 TABLET: CART-3 13:09 PROPOFOL 200 MG (20 ML) BUT REGISTERED 210 MG (21 ML) 13:18 CEFAZOLIN 1000 MG (10.0 ML) BUT REGISTERED 1050 MG (10.5 ML) 14:20 ONDANSTRON HCL 4 MG (2 ML) BUT REGISTERED 2 MG (1 ML)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574521 ↗
• MalfunctionMar 17, 2021Failure to Transmit Record; Failure to Transmit Record

  IT WAS REPORTED THAT KIT TABLET RECORDED THE INCORRECT DOSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, BATCH NO. 91DF1F51 IT IS REPORTED PRODUCT RECORDED INCORRECT DOSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510135 ↗
• MalfunctionMar 16, 2021Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT THE KIT TABLET EXPERIENCED INCORRECT DRUG/CONCENTRATION/DOSING REPORTED/RECORDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, BATCH NO. 91DF1F51 DOSE MISMATCH. TIME 08:01. SENSOR #9430 TABLET: CART-2. 08:01 - CEFAZOLIN 1000 MG (TOTAL 2G). CLINICIAN RESEARCH COORDINATOR WHO SUBMITTED THE COMPLAINT STATED THE DOSE REGISTERED AS 1050 MG INSTEAD OF 1000 MG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11492233 ↗
• MalfunctionMar 15, 2021Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT KIT TABLET RECORDED INCORRECT DOSAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, BATCH NO. BB4XR02. IT IS REPORTED CUSTOMER EXPERIENCED INCORRECT DOSAGE RECORDING WHEN USING PRODUCT. VERBIAGE RECEIVED, - "CASE # (B)(4): TIME 11:53 A.M. TABLET: CART-2. CUSTOMER SAID "WHEN I WALKED INTO THE OR TO CLOSE DOWN THE CASE THE TABLET WAS SHOWING "INTELLIPORT SYSTEM IS DOWN. PLEASE CONTACT A NETWORK ADMINISTRATOR". I WAS ABLE TO RESTART THE TABLET AND BRING BACK THE CASE TO PROPERLY CLOSE IT OUT. I JUST WANTED TO BRING THIS UP TO YOUR ATTENTION IN CASE YOU WANTED TO INVESTIGATE THIS. CRNA SAID THAT HE WAS ABLE TO ADMINISTER ALL MEDICATIONS BEFORE THIS EVEN HAPPENED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11483403 ↗
• MalfunctionMar 12, 2021Failure to Transmit Record; Failure to Transmit Record

  IT WAS REPORTED THAT 8 KIT TABLETS EXPERIENCED INCORRECT DRUG CONCENTRATION/DOSING REPORTED/RECORDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, BATCH NO. BY0F7Z1. DOSE MISMATCH: CASE #140: TIME 14:40. SENSOR #9478 TABLET: CART-3; 12:32 - FENTANYL -GIVEN 200MCG DISPLAYED AS 225MCG; 14:26- VECURONIUM-GIVEN 2MG DISPLAYED AS 2.5MG; 14:36 - ZOFRAN-GIVEN 4MG DISPLAYED AS 3MG. CASE #141: TIME 18:42. SENSOR #9401 TABLET: CART-3 16:20 - MIDAZOLAM - GIVEN 2MG DISPLAYED AS 2.5MG 16:32- ANCEF - GIVEN 1000MG DISPLAYED AS 1050 MG 16:32- ANCEF - GIVEN 1000MG DISPLAYED AS 1050 MG 17:31- VECURONIUM-GIVEN 2MG DISPLAYED AS 2.5 MG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474188 ↗
• MalfunctionMar 10, 2021Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT THE KIT TABLET WAS NOT RECORDING THE MEDICATION DOSAGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CASE #134: TIME 10 A.M. TABLET: CART-3. 1) 10:00 CUSTOMER GAVE VECURONIUM-2 MG OUSIDE THE INTELLIPORT. ADDITIONAL INFO: THE DRUG WAS GIVEN WITHOUT USING THE INTELLIPORT SENSOR AND HENCE WAS NOT RECORDED ON TABLET. 2) 10:46: CRNA PUSHED THROUGH 2MG VECURONIUM, WHICH DID NOT GET REGISTERED. SHE ALSO DID NOT HEAR THE TABLET SAYING "VECURONIUM" AS SHE ATTACHED AND PUSHED THROUGH THE MEDICATION. ON SELECT MED POPUP, SHE ACCIDENTLY CHOSE NICARDIPINE. SHE THEN PUT 0 AS THE DOSE SINCE NICARDIPINE WAS NOT A MEDICATION THAT WAS GIVEN AT THE TIME. CUSTOMER SAID SHE DID NOT HAVE AN OPTION TO ADD THE DRUG DOSE FOR VECURONIUM (WHICH DID NOT REGISTER FOR HER INITIALLY) NOTE: CUSTOMER USED THE SAME VECURONIUM SYRINGE LATER AND HAD NO ISSUES THE SECOND TIME SHE USED IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458155 ↗
• MalfunctionMar 9, 2021Wireless Communication Problem; Application Program Freezes or Fails to Launch; Wireless Communication Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT 2 KIT TABLETS EXPERIENCED INTELLIPORT REBOOTING DURING CASE, AND TABLET AND INTELLIPORT SENSOR COMMUNICATION FAILING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, SERIAL NO. (B)(6). GW. CASE #128: TIME 06:30 A.M. SENSOR #9523 TABLET: CART-4. THE "RECEIVER" WAS NOT STARTED IN THE 7EDIT PROGRAM ON GW- CCE. SO WHEN THE CASE WAS CLOSED THE MESSAGE NEXT TO ALL MEDICATIONS WAS SAYING "SENDING" INSTEAD OF "SENT". CUSTOMER CONTACT BD SUPPORT( KRUTI) AND AS PER ADVICE, CLOSED THE CASE, RESTARTED THE RECEIVER FOR THE NEXT CASE. NO FURTHER ISSUES REPORTED. TABLET - SCREEN FREEZE. CASE #129: TIME 12:14 P.M. SENSOR #9542 TABLET: CART-4. CUSTOMER REPORTED THAT THE SCREEN WAS NOT WORKING FOR HER AND CRNA COULD NOT VERIFY MEDICATION DOSES. SHE TRIED TO CLICK "OK" TO VERIFY DOSES WITHOUT ANY SUCCESS, CONTACTED BD SUPPORT. BD SUPPORT WAS ABLE TO DO THINGS ON TABLET 4 REMOTELY, BUT CUSTOMER COULD NOT. CUSTOMER PAUSED THE CASE, RESTARTED THE TABLET AND EVERYTHING STARTED WORKING AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441321 ↗
• MalfunctionMar 3, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT KIT TABLET HAD INCORRECT DOSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, SERIAL NO. (B)(6). IT WAS REPORTED CUSTOMER EXPERIENCED MISMATCH DOSING WHEN USING PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408241 ↗
• MalfunctionMar 3, 2021Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE KIT TABLET REBOOTED WHILE IN THE MIDDLE OF RESOLVING MEDICATIONS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TABLET SHUTDOWN TABLET ¿ CART 2, CASE ¿ 117 THE CUSTOMER WAS IN THE MIDDLE OF RESOLVING MEDICATIONS AND THE TABLET REBOOTED. THE MESSAGE " INTELLIPORT SYSTEM DOWN. PLEASE CONTACT A NETWORK ADMINISTRATOR" SHOWED UP. CUSTOMER LOGGED BACK INTO THE TABLET AND PATIENT SETUP SCREEN SHOWED UP THE CASE. CUSTOMER RECONNECTED AND THEN SELECTED CLOSE DOWN PORTS OPTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402982 ↗
• MalfunctionFeb 26, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT KIT TABLET REPORTED INCORRECT DOSING. THIS OCCURRED ON 11 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, BATCH NO. BY0F7Z1. IT IS REPORTED CUSTOMER EXPERIENCED INCORRECT REPORTING OF DOSAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11389231 ↗
• MalfunctionFeb 26, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE KIT TABLET RECORDED THE INCORRECT DOSES. THIS OCCURRED 8 SEPARATE TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DOSE MISMATCH CASE # (B)(4): TIME 09:00 A.M. SENSOR #9365. 07:45 - PROPOFOL -SHOULD HAVE BEEN ZERO. WAS NS FLUSH, BUTTON CLICKED WRONG. 07:46 - FENTANYL -GIVEN 100MCG. 07:47 - PROPOFOL -GIVEN 160MG. 08:09 - CEFAZOLIN -GIVEN 500MG. 08:10- CEFAZOLIN-GIVEN 1000MG.(TOTAL 2000MG) 19:31 VECURONIUM - GIVEN 3MG. CASE # (B)(4): TIME 12:40 P.M. SENSOR #9400: 12:20 - PROPOFOL -GIVEN 180MG. 13:02 VECURONIUM - GIVEN 2MG. UNABLE TO RELY ON INSTRUMENT MEASUREMENTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11386665 ↗
• MalfunctionFeb 22, 2021Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THERE WAS A DELAY WHILE USING KIT TABLET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, SERIAL NUMBER. BY0F7Z1 IT IS REPORTED CUSTOMER EXPERIENCED DELAY IN MEDICATION DELIVERY. VERBIAGE RECEIVED, - TABLET SHUTDOWN CASE #094: TIME 10:00 A.M. SENSOR #9254 ISSUES: CRNA WAS TRYING TO ADD AND CONFIRM A DOSE(SUGAMMADEX) ON TABLET 3 AND TABLET 3 WENT TO THE SCREEN SAYING THE SYSTEM IS DOWN AND TO CONTACT THE ADMINISTRATOR. THERE WAS NO YELLOW BANNER *GATEWAY NOT CONNECTED. ALLERGIES MAY NOT BE CURRENT. CRNA SAID THAT SHE DID NOT DISCONNECT THE BASE FROM THE SENSOR PRIOR TO THIS. CUSTOMER ALSO SAID "IT WAS THE SAME SCREEN FOR A WHILE THEN I RESTARTED THE TABLET TO SET UP FOR THE NEXT CASE AS IT WASN¿T CHANGING. AFTER I RESTARTED IT WENT BACK TO ¿WAITING FOR THE CASE TO BEGIN¿.THE SECOND CASE AFTER THIS INCIDENT WENT PERFECTLY FINE THOUGH. I DID NOT RESTART THE TABLET THIS MORNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11362776 ↗
• MalfunctionFeb 16, 2021Communication or Transmission Problem

  IT WAS REPORTED THAT KIT TABLET HAD INCORRECT DOSING RECORDING. THIS OCCURRED ON 8 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 516704, SERIAL NO. (B)(4). IT IS REPORTED CUSTOMER EXPERIENCED INACCURATE DOSE RECORDING. VERBIAGE RECEIVED, - "DOSE MISMATCH, SENSOR # 9221; CASE ID: (B)(4), 11:52 - PROPOFOL -GIVEN 200MG, RECORDED AS 225MG; 12:02 - CEFAZOLIN -GIVEN 1000 MG, 12:02 - CEFAZOLIN -GIVEN 1000 MG, 14:19 - FENTANYL -GIVEN 50MCG. SENSOR # 9171; CASE ID: (B)(4), 16:21 - PROPOFOL -GIVEN 200MG, 16:21 - VECURONIUM BROMIDE - GIVEN 7MG, 16:30 - CEFAZOLIN -GIVEN 1000 MG ( TOTAL 2000MG), 17:07 VECURONIUM BROMIDE - GIVEN 3MG."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11336251 ↗