MAUDE Adverse Event Report: BEST NOMOS CRADLE, BK 8848; SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL

Model Number	6211
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: CRADLE, BK 8848
• Common Device Name: SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL
• Manufacturer (Section D): BEST NOMOS; 1 best drive; pittsburgh PA 15202
• MDR Report Key: 13659283
• Report Number: 13659283
• Device Sequence Number: 5111530
• Product Code: IWJ
• UDI-Device Identifier: 00852656007144
• UDI-Public: (01)00852656007144
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/15/2022
• Report Date (Section F): 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6211
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 02/15/2022