Bravo FGS-0450Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 07290101363064), received between Jul 6, 2017 and Mar 2, 2020 — classified as 77 malfunctions.

The most frequently reported specific device problem is “Unintended Application Program Shut Down” (15 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2020Loss of Data; Loss of Data

  ACCORDING TO THE REPORTER, THEY HAD A LOST REPORT/DATA AND THE CUSTOMER LOST CONFIDENCE IN USING THE RECORDER. THEY WERE UNABLE TO DOWNLOAD ANY OF THE PATIENT'S RECORDINGS. WHEN THE RECORDER WAS CONNECTED TO A COMPUTER, THEY RECEIVED AN ERROR "CE-DO NOT SUPPORT". A REPEAT PROCEDURE SCHEDULED ON ANOTHER DAY WAS NECESSARY. THE RECORDER WORKED CORRECTLY DURING PREVIOUS PROCEDURE. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9775768 ↗
• MalfunctionJan 20, 2020Loss of Data; Insufficient Device Problem Information; Loss of Data; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE RECORDER SHOWED AN ERROR MESSAGE OF "EEFACE" WHEN THEY TRIED TO UPLOAD A STUDY. TECHNICAL SUPPORT INFORMED THE CUSTOMER IT WAS INDICATED THERE WAS NO DATA SAVED TO THE RECORDER TO UPLOAD. TECHNICAL SUPPORT HAD THE CUSTOMER SELECT START STUDY AND THE RECORDER STARTED LOOKING FOR A CAPSULE INDICATING THAT THE RECORDER WAS READY FOR A STUDY. A REPEAT PROCEDURE WILL BE PERFORMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9607057 ↗
• MalfunctionJan 6, 2020Loss of Power; Failure to Transmit Record; Loss of Data; Insufficient Device Problem Information; Loss of Power; Failure to Transmit Record; Loss of Data; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE RECORDER TURNED OFF. THE PATIENT WAS INSTRUCTED TO REMOVE THE RECORDER FROM THE CASE AND TO PRESS THE POWER BUTTON TO TURN IT BACK ON. AFTER THE PATIENT RETURNED TO THE OFFICE, AN ATTEMPT WAS MADE TO UPLOAD THE STUDY BUT AND EFFACE ERROR KEPT PROMPTING, THIS MEANT THAT THERE WERE NO DATA ON THE IN THE RECORDER. THEY WERE ALSO INFORMED THAT THE STUDY AND THE CALIBRATION DATA WERE CLEARED AND WILL BE UNABLE TO CONTINUE WITH THE STUDY. THE POWER BUTTON ON THE RECORDER WAS DAMAGED. THE RECORDER WORKED CORRECTLY ON THE PREVIOUS PROCEDURE. A REPEAT PROCEDURE WILL BE NECESSARY. THERE WAS NO USER OR PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9554679 ↗
• MalfunctionDec 9, 2019Activation, Positioning or Separation Problem

  THE BRAVO CAPSULE APPEARED TO HAVE DEPLOYED. THE PHYSICIAN RESCOPED THE PATIENT TO SEE VERIFY PLACEMENT, AND FOUND THAT THE BRAVO WAS NOT IN POSITION. UPON REMOVAL OF THE SCOPE, THE BRAVO WAS NOTED TO BE IN THE BACK OF THE PATIENT'S THROAT.

  Patient problems: No Code Available

  MAUDE report 9437016 ↗
• MalfunctionDec 4, 2019Signal Artifact/Noise; Signal Artifact/Noise

  ACCORDING TO THE REPORTER, THERE WAS A MISSING TRACES IN THE STUDY. TECHNICAL SUPPORT LOGGED INTO THE CUSTOMER¿S COMPUTER AND COLLECTED THE STUDY. THERE WAS NO PATIENT HARM AND USER HARM AND NO IMPLANTED DEVICES. A REPEAT PROCEDURE WAS NECESSARY DUE TO DEVICE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9407669 ↗
• MalfunctionNov 18, 2019Signal Artifact/Noise; Signal Artifact/Noise

  ACCORDING TO THE REPORTER, THERE WAS AN ISSUE WITH THE STUDY INFORMATION OBTAINED FROM THE DEVICE. A REPEAT PROCEDURE WAS NECESSARY. THE RECORDER WORKED CORRECTLY ON THE PREVIOUS PROCEDURE. THERE WAS NO USER OR PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9338998 ↗
• MalfunctionNov 18, 2019Loss of Power; Loss of Power

  ACCORDING TO THE REPORTER, THE CUSTOMER STATED THEY SUCCESSFULLY CALIBRATED THE CAPSULE BUT AFTER DEPLOYMENT THE RECORDER POWERED OFF. WHEN THEY POWERED IT BACK ON, THE RECORDER WAS PROMPTING FOR CALIBRATION. THEY ADVISED THAT "CALIBRATE," AND NOT "START STUDY" WAS SELECTED. A REPEAT PROCEDURE ON A DIFFERENT DAY WAS NECESSARY. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9338914 ↗
• MalfunctionOct 25, 2019Failure to Power Up; Failure to Power Up

  ACCORDING TO THE REPORTER, THE RECORDER FAILED TO SWITCH ON AND WAS NOT RECOGNIZED BY THE COMPUTER. THE RECORDER WORKED CORRECTLY ON THE PREVIOUS PROCEDURE. A REPEAT PROCEDURE WILL BE PERFORMED. THERE WAS NO USER OR PATIENT HARM.

  Patient problems: No Information

  MAUDE report 9242279 ↗
• MalfunctionOct 24, 2019Unintended Application Program Shut Down; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THEY HAD A SHORT STUDY. THEY ATTEMPTED TO UPLOAD THE STUDY FOUR TIMES. THE FIRST TIME THEY DID, A DIARY AND A STUDY OF AN HOUR AND FIVE MINUTES WERE PRODUCED, WHILE THE THREE CONSECUTIVE TRIES PRODUCED THE SHORT STUDY WITH NO DIARY. A COPY OF THE STUDY WAS SENT IN FOR REVIEW. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT AND USER HARM AND A REPEAT PROCEDURE WAS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234710 ↗
• MalfunctionSep 16, 2019Loss of Power; Unintended Application Program Shut Down; Loss of Power; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THE RECORDER TURNED OFF AFTER ONLY 25 MINUTES. TECHNICAL SUPPORT CONNECTED TO THE SYSTEM AND CONFIRMED A SHORT STUDY. THERE WAS NO PATIENT AND USER HARM. A REPEAT PROCEDURE ON A DIFFERENT DAY WAS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9072933 ↗
• MalfunctionSep 15, 2019High pH; High pH

  ACCORDING TO THE REPORTER, THEY HAD A STUDY WITH A HIGH PH FOR THE MAJORITY OF IT. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. A REPEAT PROCEDURE WAS SCHEDULED ON A DIFFERENT DAY. THERE WAS NO PATIENT OR USER INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9068486 ↗
• MalfunctionSep 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE CAPSULE FAILED TO TRANSMIT. THE PATIENT DOES NOT HAVE IMPLANT DEVICES NOR A TELEMETRY. THE RECORDER WAS THEN PLACED ON THE PATIENT'S CHEST AND IT RECONNECTED WITH THE CAPSULE, HOWEVER, IT STILL DISCONNECTED WHENEVER THE PATIENT MOVES. THIS WAS A 48-HOUR STUDY. A REPEAT PROCEDURE ON DIFFERENT DAY WAS PERFORMED AS THE FIRST PROCEDURE DELIVERED ZERO INFORMATION. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8973419 ↗
• MalfunctionAug 25, 2019Failure to Transmit Record; Failure to Transmit Record

  ACCORDING TO THE REPORTER, THEY WERE UNABLE TO UPLOAD THE STUDY BECAUSE THE RECORDER WAS NOT DETECTED. THEY DID A HARD RESET TO THE RECORDER, SWAPPED THE USB PORTS, AND THE ISSUE PERSISTED. THEY WERE ABLE TO DETECT A SECOND RECORDER. THE CUSTOMER WAS REQUESTING FOR A DATA EXTRACTION. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE AND HAS BEEN RETURNED FOR INVESTIGATION. THEY ATTEMPTED TO UPLOAD THE STUDY AND THE USB PORT WAS WORKING ON THE RECORDER, BUT THE RECORDER WAS NOT RECOGNIZED BY THE COMPUTER AND WOULD NOT CHARGE. THERE WAS NO PATIENT AND USER HARM AND A REPEAT PROCEDURE WAS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8928934 ↗
• MalfunctionAug 21, 2019Unintended Application Program Shut Down; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THEY HAD A 96-HOUR STUDY THAT ENDED EARLY AND ONLY 47 MINUTES WERE RECORDED. A COPY OF THE STUDY WAS SENT IN FOR REVIEW. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT AND USER HARM AND A REPEAT PROCEDURE WAS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8918881 ↗
• MalfunctionAug 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE RECORDER DID NOT CALIBRATE THE CAPSULE. THEY USED ANOTHER CAPSULE, BUT THE RECORDER STILL DID NOT CALIBRATE IT. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE AND WILL BE RETURNED FOR INVESTIGATION. THERE WAS NO PATIENT AND USER HARM AND A REPEAT PROCEDURE WAS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8913500 ↗
• MalfunctionAug 9, 2019Poor Quality Image; Unintended Application Program Shut Down; Poor Quality Image; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THEY HAD A SHORT STUDY OF 27 HOURS. TECHNICAL SUPPORT REMOTELY ACCESSED THE COMPUTER TO VERIFY THE STUDY AND VERIFIED THAT THEY HAD BLUE LINES THROUGHOUT THE STUDY. THE CUSTOMER STATED THAT THE PATIENT SAW "LI" ON THE SCREEN AS WELL. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT OR USER HARM AND A REPEAT PROCEDURE WAS SCHEDULED WITH ADDITIONAL ANESTHESIA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8880727 ↗
• MalfunctionJul 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE RECORDER SHOWED "CAPSULE ID MISMATCH 0000" AT THE START OF THE PROCEDURE WHEN THE CAPSULE WAS INSERTED TO THE PATIENT. THEY WERE UNABLE TO START THE PROCEDURE AND THE PATIENT WILL HAVE TO RETURN IN A FEW WEEKS FOR ANOTHER PROCEDURE. THE RECORDER WORKED CORRECTLY DURING PREVIOUS PROCEDURE. THE CAPSULE PASSED THOUGH THE PATIENT. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813112 ↗
• MalfunctionJun 28, 2019Unintended Application Program Shut Down; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THEY HAD A SHORT STUDY. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT AND USER HARM. A REPEAT PROCEDURE ON A DIFFERENT DAY WAS NEEDED AND THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746104 ↗
• MalfunctionJun 27, 2019Loss of Power; Loss of Power

  ACCORDING TO THE REPORTER, THE RECORDER ACCIDENTALLY BANGED ON THE FURNITURE WHILE THE PATIENT WAS MAKING THE BED. THE RECORDER PROMPTED A MESSAGE ASKING FOR IT TO BE SWITCHED OFF WHEN THE PATIENT CHECKED IT, AND DECIDED NOT TO DO ANYTHING ABOUT IT. THE PATIENT DISCOVERED THAT THE RECORDER WAS TURNED OFF A FEW MINUTES LATER. THE PATIENT THEN TRIED TO POWER THE RECORDER ON, BUT IT DISPLAYED A MESSAGE STATING THAT THE STUDY NEEDED TO BE DOWNLOADED. THE PROCEDURE WAS MEANT TO BE FOR 48 HOURS, HOWEVER, IT HAD ONLY BEEN LESS THAN 24 HOURS WHEN THE RECORDER SWITCHED OFF. THE CUSTOMER WAS ADVISED TO DOWNLOAD THE STUDY, BUT THEY DECIDED TO REPEAT THE PROCEDURE INSTEAD. THE RECORDER WORKED CORRECTLY DURING A PREVIOUS PROCEDURE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8740065 ↗
• MalfunctionJun 26, 2019Signal Artifact/Noise; Unintended Application Program Shut Down; Signal Artifact/Noise; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THEY HAD A SHORT STUDY. TECHNICAL SUPPORT LOGGED INTO THE CUSTOMER'S COMPUTER AND CONFIRMED THAT INSTEAD OF 48 HOURS, THE STUDY WAS ONLY 23:50 HOURS AND THERE WERE ALSO A NUMBER OF "IGNORES" IN THE STUDY BECAUSE THE CAPSULE FELL OFF. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT AND USER HARM AND A REPEAT PROCEDURE WAS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8733269 ↗
• MalfunctionJun 24, 2019Poor Quality Image; Poor Quality Image

  ACCORDING TO THE REPORTER, THEY HAD A STUDY WITH BLUE LINES THROUGHOUT IT. TECHNICAL SUPPORT REMOTELY ACCESSED THE COMPUTER AND VERIFIED THE INFORMATION. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. A REPEAT PROCEDURE WAS NECESSARY THOUGH THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8729721 ↗
• MalfunctionJun 19, 2019Loss of Power; Noise, Audible; Loss of Power; Noise, Audible

  ACCORDING TO THE REPORTER, THE PATIENT COMPLAINED THAT THE RECEIVER BEEPED WHEN HE EXPERIENCED TWO OCCASIONS OF CHEST PAIN IMMEDIATELY AFTER DRINKING COLD WATER AND REGURGITATION THAT CAUSED PROMPT THROAT IRRITATION. DURING EXERCISE, THE HEARTBURN WAS VERY NOTICEABLE WITH A MILD THROAT IRRITATION. ALSO, THE PATIENT NOTED THAT THE RECORDER TURNED OFF. THE TRANSMISSION OF THE CAPSULE TO THE RECEIVER WAS WEAKENED OR PAUSED WHEN THE PATIENT MARKED THE SYMPTOMS. THERE WAS NO INTERVENTION REQUIRED BECAUSE OF THE ISSUE AND NO REPEAT PROCEDURE. A LUBRICANT WAS USED TO FACILITATE CAPSULE PLACEMENT. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: Chest Pain; Heartburn/Indigestion

  MAUDE report 8712779 ↗
• MalfunctionMay 23, 2019No Display/Image; No Display/Image

  ACCORDING TO THE REPORTER, THE STUDY COULD NOT BE FOUND ON THE RECORDER. THEY CARRIED OUT A PROCEDURE BUT IT APPEARED THEY DID NOT PERFORM IT CORRECTLY AND THE STUDY WAS NOT STARTED. A REPEAT PROCEDURE SCHEDULED ON A DIFFERENT DAY WAS NECESSARY. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636557 ↗
• MalfunctionMay 20, 2019Signal Artifact/Noise; Signal Artifact/Noise

  ACCORDING TO THE REPORTER, THEY HAD A STUDY WHICH HAD A NUMBER OF "IGNORES." TECHNICAL SUPPORT WAS ABLE TO LOG IN TO THE CUSTOMER'S COMPUTER AND OBSERVED THE NUMBER OF FAILURES THROUGHOUT THE STUDY. A COY OF THE STUDY WAS SENT IN FOR REVIEW. THE RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT AND USER HARM AND A REPEAT PROCEDURE WAS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8625550 ↗
• MalfunctionMay 14, 2019Loss of Power; Loss of Power

  ACCORDING TO THE REPORTER, THE RECORDER CONTINUED TO POWER OFF RANDOMLY. THEY USED ANOTHER RECORDER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT AND USER HARM AND A REPEAT PROCEDURE WAS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8608597 ↗