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

Model Number 86640

Device Problem Power Conditioning Problem (1474)

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

Event Date 05/27/2020

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 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.

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 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
• Type of Device: AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10185240
• MDR Text Key: 196118828
• Report Number: 2134265-2020-08399
• Device Sequence Number: 1
• Product Code: DRQ
• UDI-Device Identifier: 08714729885887
• UDI-Public: 08714729885887
• Combination Product (y/n): N
• PMA/PMN Number: K152693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 86640
• Device Catalogue Number: 86640
• Device Lot Number: 1A909595
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 09/22/2020
• Patient Sequence Number: 1