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

Model Number	M00542760
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, (b)(6) 2024, was chosen as a best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2024.Block h6: device code a0203 is being used to capture the reportable event of the exalt model b monitor ac power adapter catching fire.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model b monitor was used on an unknown procedure performed on an unknown date.During preparation for the procedure, the ac power adapter for the monitor was brought into patient's room and plugged into the wall.As it was plugged in, it was reported that flames shot out of the power supply, melting part of the power supply and power cord, and leaving a black residue on the monitor stand.The ac adapter was then promptly removed from the wall.The procedure was successfully completed using the original monitor.The facility discontinued use of the damaged power adapter.No injuries, patient complications, or other damage were reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model b monitor was used on an unknown procedure performed on an unknown date.During preparation for the procedure, the ac power adapter for the monitor was brought into patient's room and plugged into the wall.As it was plugged in, it was reported that flames shot out of the power supply, melting part of the power supply and power cord, and leaving a black residue on the monitor stand.The ac adapter was then promptly removed from the wall.The procedure was successfully completed using the original monitor.The facility discontinued use of the damaged power adapter.No injuries, patient complications, or other damage were reported as a result of this event.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, 02/01/2024, was chosen as a best estimate based on the date that the manufacturer became aware of the event, 02/20/2024.Block h6: device code a0203 is being used to capture the reportable event of the exalt model b monitor ac power adapter catching fire.Block h11: with all the available information, boston scientific concludes the reported event was confirmed.The returned exalt model b power adapter was analyzed.Visual examination of the device identified heavy carbon charring at the input end at the iec connector and the ac input cord.It was noted that a portion of the base of the copper/bronze ground pin has been melted away due to an ac electrical short to the ac blade.Signs of liquid residue at the iec end of the power supply was observed along with circle water drop residue seen on top left corner and white streaking seen in lower left corner of the iec connector.The bottom of the power supply housing had a series of liquid splash streaks which were not coming from the ac inlet but from the side.This residue is raised and sticky.This fluid flowed between the ac input connector and the power supplys iec inlet, causing a short from the ac line to the ground pin.This causes the instantaneous short meltdown, copper blade vaporizing, the soot and the flame.The reported allegation was confirmed.A labeling review was performed.The ifu includes specific instructions such as: do not allow fluids to enter the enclosure, power cable connections, single use endoscope cable receptacle, or component accessory connections.Do not spray cleaning solution directly onto exalt monitor.Do not clean using abrasive materials as this may scratch the exalt monitor touchscreen.Do not attempt to clean the unit while it is plugged into an electrical outlet.Ensure that the exalt monitor is completely dry before reconnecting to power.Based on all the available information, a conclusion code of unintended use error caused or contributed to event, which means the interaction between the user and device, or sample, could cause or contribute to the reported event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18934827
• Report Number: 3005099803-2024-01149
• Device Sequence Number: 20593637
• Product Code: EOQ
• UDI-Device Identifier: 00191506007805
• UDI-Public: 00191506007805
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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: 0022181020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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