MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT B MONITOR; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00542760
Medical Device Problem Codes	Overheating of Device (1437); Failure to Power Up (1476); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an exalt b monitor was being charged.No procedure was performed during that time.While charging, the power supply cable and the monitor screen became hot.The monitor and power supply were then unplugged.When the charging cable was plugged back into the monitor, it wouldn't charge.There was no patient involvement in this event.
Additional Manufacturer Narrative
Block h6 (device codes): problem code a1005 captures the reportable event of overheating of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that an exalt b monitor was being charged.No procedure was performed during that time.While charging, the power supply cable and the monitor screen became hot.The monitor and power supply were then unplugged.When the charging cable was plugged back into the monitor, it wouldn't charge.There was no patient involvement in this event.
Additional Manufacturer Narrative
Block h6 (device codes): problem code a1005 captures the reportable event of overheating of device or device component block h11: the returned exalt model b monitor was analyzed, the unit was received with 113 saved procedures and completely discharged, the power supply cord was severely damaged.The power cable was damaged and severed due to environmental stresses and possible misuse.The power supply cord damaged could have affected the device performance and its integrity leading to the event experienced by the customer.With all the available information, boston scientific concludes the overheating of the power adaptor the reported event was confirmed.Since an expected or random component failure was identified without any design or manufacturing issue, the conclusion code of cause traced to component failure is selected for the complaint.

• Brand Name: EXALT B MONITOR
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): TRICE MEDICAL INC; 40 general warren blvd; suite 100; malvern PA 19355 ; CS 19355
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 20279944
• Report Number: 3005099803-2024-04631
• Device Sequence Number: 7980129
• Product Code: EOQ
• UDI-Device Identifier: 00191506007805
• UDI-Public: 00191506007805
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K211030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: M00542760
• Device Catalogue Number: 2295-05
• Device Lot Number: 0021138034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown