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.
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 device has been evaluated onsite by boston scientific and the reported signal quality/noise issue complaint was confirmed.When the bsc representative visited the customer site, the bsc representative found that the ecg cable being used was not connected to the amplifier correctly and was too long.It was 6 meters long.The ecg cable was replaced to a 3 meter long cable and connected properly to the amplifier and all the noise problems were resolved.This investigation is assigned the most probable conclusion code of unintended use error cause or contributed to event.This conclusion was selected, because the signal quality/noise was due to a system setup issue.Changing to a shorter cable and making sure the cable was properly secured resolved the issue.A longer cable acted like an attenna allowing electrical noise in.The bad connection, did not properly shield and ground out noise signals.There was no issue with the amplifier, it operated within specifications.Product investigation did not find anything that would have contributed to the reported complaint.It did not identify any potential quality issue or any new patient harm.It can be concluded at this point that unintended factors most probably contributed to the reported event.

• 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: 10183799
• Report Number: 2134265-2020-08367
• Device Sequence Number: 886204
• 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): 08/18/2020

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: 07/28/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1