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

Model Number	86640
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was reported for the amp not turning on.Visual inspection of the device revealed that it was received in good condition with no visible damage.During functional testing it was confirmed that the amplifier will not turn on, the led power did not light and the fan did not turn on.It was also revealed that 2 fuses had continuities.
Event or Problem Description
It was reported hat the procedure was canceled.It was reported that a clearsign amp, 80 was selected for a procedure.It was noted that the amp did not turn on and the issue was unable to be resolved.It was not reported if the patient was sedated prior to this issue but no patient complications were reported.

• 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
• MDR Report Key: 10482836
• Report Number: 2134265-2020-12193
• Device Sequence Number: 3860222
• Product Code: DRQ
• UDI-Device Identifier: 08714729883302
• UDI-Public: 08714729883302
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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: 1A959075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 09/02/2020
• Patient Sequence Number: 1