MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LABSYSTEM PRO; AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL

Model Number	86640
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the labsystem pro clearsign amplifier power supply "blew up, and that it appeared to have exploded".The issue occurred during training so there was no patient involvement.The training was discontinued.The amplifier is not expected to be returned as it was serviced on site.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: LABSYSTEM PRO
• Common Device Name: AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14044745
• Report Number: 2134265-2022-04125
• Device Sequence Number: 20054762
• Product Code: DRQ
• UDI-Device Identifier: 08714729885849
• UDI-Public: 08714729885849
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K152693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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: 86640
• Device Catalogue Number: 86640
• Device Lot Number: 1D106124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2018
• 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