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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that prior to a procedure a labsystem pro amplifier was selected for use.The amplifier would not turn on and it appeared to be due to a power issue.The procedure was cancelled, the sedation status of the patient was not provided.No patient complications were reported.It is unknown if the amplifier will be returned for analysis.

Manufacturer Narrative

The clearsign ii amplifier was returned to boston scientific for analysis.Upon receipt at our post market quality assurance laboratory the amplifier underwent visual inspection and functional testing.On visual inspection the clearsign amplifier was in good condition, but the power connector at the rear of the device was damaged.The amplifier also failed the amplifier functional feature test.The amplifier could not power on due to a damaged power connector.The reported clinical observation was confirmed by the device analysis.

Event Description

It was reported that prior to a procedure a labsystem pro amplifier was selected for use.The amplifier would not turn on and it appeared to be due to a power issue.The procedure was cancelled.No patient complications were reported.The amplifier was returned for analysis.

• 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: 17472172
• MDR Text Key: 320632537
• Report Number: 2124215-2023-39457
• Device Sequence Number: 1
• Product Code: DRQ
• UDI-Device Identifier: 08714729885887
• UDI-Public: 08714729885887
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K152693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• 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: 1D453582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1