Cradle, BK 8848 6211Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00852656007144), received between Mar 3, 2022 and Mar 3, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2022Device Displays Incorrect Message; Output Problem

  PRIOR TO PATIENT COMING INTO OPERATING ROOM, PHYSICIST & MD HOOKED UP BK ULTRASOUND PROBE, AND WAS WORKING FINE, NO ISSUES. PATIENT CAME INTO OPERATING ROOM AND JUST AFTER PATIENT WAS PUT TO SLEEP BY ANESTHESIA, AN ERROR MESSAGE CAME UP ON THE BK ULTRASOUND STATING: HARDWARE ERROR: HIGH VOLTAGE ERROR IN TRANSDUCER, WHICH CAUSED IT TO TURN OFF THE MACHINE AND RESTART. MULTIPLE ATTEMPTS TO GET IT TO WORK, BIOMED CALLED AND WAS UNABLE TO GET IT TO WORK. BK SERVICE REP CALLED AND STATED SOUNDS LIKE WATER GOT INTO TRANSDUCER AND WAS SHORTING IT OUT. UNABLE TO ACCESS A NEW PROBE. DOCTOR DECIDED TO ABORT ATTEMPTS. PATIENT WOKE UP FROM ANESTHESIA AND BROUGHT TO PACU. NO HARM TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659283 ↗