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

Model Number 86620

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

Event Type  malfunction  

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.

Event Description

It was reported that during preparation for a procedure using a ls pro amplifier they received an error message.They were unable to resolve the issue and the procedure was canceled.It was reported the patient is stable and that there were no patient complications, however, the sedation status of the patient at the time the procedure was canceled is unknown despite good faith attempts to obtain the information.

• 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: 11922515
• MDR Text Key: 253806624
• Report Number: 2134265-2021-07143
• Device Sequence Number: 1
• Product Code: DRQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86620
• Device Catalogue Number: 86620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1