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	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ac power adapter for the exalt model b monitor was generating smoke and smelled of burnt plastic on (b)(6) 2024.Boston scientific has been unable to obtain additional information, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: device code a0203 is being used to capture the reportable event of the exalt model b monitor ac power adapter generating smoke.
Additional Manufacturer Narrative
Block h6: device code a0203 is being used to capture the reportable event of the exalt model b monitor ac power adapter generating smoke.Block h11: the returned ac power adapter for the exalt model b monitor was analyzed.Visual inspection showed surface scrapes and scuffs from normal field use over time.The output connector/op cord show strong right-angle memory in the cable bend but appears intact.A white residue was observed in at the unput end surrounding the ac inlet.A slight burnt plastic smell was present.When plugged in, the unit has no output, and the led does not light.A burn mark is seen at the tip of the neutral blades on the iec c14 connector.Upon removal of the circuit assembly from the housing, it is apparent that liquid ingress occurred.The liquid entered from around the iec input connector.Liquid flow is seen on the black housing and onto points on the circuit board.This liquid caused shorts on the board as evidenced by rust and burn marks.With all the available information, boston scientific concludes that the reported event was confirmed.The device analysis presented evidence of fluid ingress, which caused the reported issue.Since the instructions for use (ifu) includes clear instructions to avoid fluid damage, "unintended use error caused or contributed to event" was selected for this case, which means the interaction between the user and device caused or contributed to the error.
Event or Problem Description
It was reported that the ac power adapter for the exalt model b monitor was generating smoke and smelled of burnt plastic on (b)(6) 2024.Boston scientific has been unable to obtain additional information, despite good faith efforts.

• 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: 19015503
• Report Number: 3005099803-2024-01198
• Device Sequence Number: 19782357
• Product Code: EOQ
• UDI-Device Identifier: 00191506007805
• UDI-Public: 00191506007805
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 0022144035
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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