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

Model Number	86640
Medical Device Problem Code	Power Conditioning Problem (1474)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that due to a device malfunction the procedure had to be cancelled.A lab system pro was selected for use.There was noise on the ecg which made the procedure difficult to perform therefore the procedure had to be cancelled.
Additional Manufacturer Narrative
The boston scientific sales representative went onsite to checked a few things before the field service engineer arrival.The sales representative found that the customer had not connected the ecg cable correctly to the amplifier and used a long 6 meter cable.The sales rep replaced the cable with a 3 meter cable and verified the connections to the amplifier, retested and found the noise issue resolved.The ecg noise was determined to be inadvertent/unintentional interaction of the product from the bsc sales rep analysis onsite and additional available information.Furthermore, bsc rep resolved the complaint by correctly connecting the ecg to the amplifier and replacing with a shorter cable.The evidence from the product record review did not identify a potential product quality issue or new patient harm.
Event or Problem Description
It was reported that due to a device malfunction the procedure had to be cancelled.A lab system pro was selected for use.There was noise on the ecg which made the procedure difficult to perform therefore the procedure had to be cancelled.

• 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: 10185240
• Report Number: 2134265-2020-08399
• Device Sequence Number: 3016418
• Product Code: DRQ
• UDI-Device Identifier: 08714729885887
• UDI-Public: 08714729885887
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K152693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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: 1A909595
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 09/22/2020
• Patient Sequence Number: 1