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.

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 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
• 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: 10183799
• MDR Text Key: 196076651
• Report Number: 2134265-2020-08367
• 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: 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
• 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: 07/28/2020
• Supplement Dates FDA Received: 08/18/2020
• Patient Sequence Number: 1