Bravo RFB-0450Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290101365303), received between Jul 25, 2018 and Mar 1, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2019Failure to Power Up; Failure to Power Up

  ACCORDING TO THE REPORTER, THE RECORDER WAS RETURNED FROM THE PATIENT WITH A STEADY RED LIGHT, BUT IT WOULD NOT TURN ON. THEY ATTEMPTED TO RESTART THE RECORDER, MULTIPLE TIMES, BUT ALL ATTEMPTS FAILED. TECHNICAL SUPPORT HAD THE CUSTOMER RESET THE RECORDER, BUT IT STILL FAILED. THE RECORDER CONTAINED THE PATIENT DATA. A REPEAT PROCEDURE WILL BE PERFORMED. THE CUSTOMER STATED THAT RECORDER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO PATIENT AND USER INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8381933 ↗
• MalfunctionJan 28, 2019Loss of Power; Insufficient Device Problem Information; Loss of Power; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, TEN AND A HALF HOURS AFTER CAPSULE PLACEMENT, THE RECORDER DISPLAYED ERROR CODE ¿386ERR_J2C024/DRIVER¿ AND IT TURNED OFF. THE CUSTOMER PRESS AND HOLD POWER BUTTON FOR 30 SECONDS, BUT THERE WAS NO RESPONSE. THE CUSTOMER THEN PRESSED CIRCLE, TRIANGLE, SQUARE AND CIRCLE BUTTONS, BUT THERE WAS NO CHANGE IN ERROR STATE. A REPEAT PROCEDURE WILL BE PERFORMED. THE CUSTOMER NOTED THAT THE RECORDER WORKED CORRECTLY DURING PREVIOUS PROCEDURE. THERE WAS NO PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR DATA EXTRACTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8283911 ↗
• MalfunctionJul 25, 2018High pH; Chemical Problem; Chemical Problem

  ACCORDING TO THE REPORTER, THEY HAD A STUDY WITH LOTS OF BLUE LINES IN IT WHICH WERE NOT ABLE TO BE ERASED. TECHNICAL SUPPORT WALKED THE CUSTOMER THROUGH THE STEPS TO DE-IDENTIFY THE STUDY AND SENT IN FOR REVIEW. UPON RECEIPT OF THE STUDY, IT SHOWED HIGH PH VALUES THROUGHOUT. THERE WAS NO PATIENT AND USER HARM AND A REPEAT PROCEDURE WILL NEED TO BE COMPLETED WITH ANESTHESIA.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7717687 ↗