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

Model Number 86640

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2020

Event Type  malfunction  

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 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
• Type of Device: 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: 10482836
• MDR Text Key: 205308535
• Report Number: 2134265-2020-12193
• Device Sequence Number: 1
• Product Code: DRQ
• UDI-Device Identifier: 08714729883302
• UDI-Public: 08714729883302
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1