MAUDE Adverse Event Report: ALPINE BIOMED APS DANTEC LEADPOINT WORKSTATION 5+3

Model Number 9031A051401

Device Problem Temperature Problem (3022)

Patient Problem Not Applicable (3189)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

This system, s/n (b)(4) (leadpoint 5+3 workstation) was apparently installed to a distributor, "(b)(4)", back in 2007 and is 12 years old.The complaint log was reviewed for this part number.No similar complaints have been received in relation to this issue.No trend has been observed.No patient impact reported.Justification for not providing below information and applicable sections: patient information - no patient injury reported, device malfunction occurred.Udi - device manufactured in 2007, udi not applicable.Relevant tests / laboratory data - this section is not applicable as no patient injury reported.Other relevant history, including preexisting medical conditions: this section is not applicable as no patient injury reported.Lot # - this section is not applicable as the medical device does not have a lot number.Expiration date - no exact date of manufacture obtained.Manufactured in 2007.The expected lifetime of leadpoint is 8 years.The service lifetime is 7 years.This device is 12 years old.If implanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable.If explanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable.Reprocessor name and address - this section is not applicable as the medical device is not a single-use device that was reprocessed or reused on a patient.For use by user facility / importer - not applicable as we are not a facility or importer of device.If nd, give protocol # - this section is not applicable as the medical device is not ind.Adverse event terms - this section is not applicable to medical devices.Device manufacture date: - no exact date of manufacture obtained.Manufactured in 2007.The expected lifetime of leadpoint is 8 years.The service lifetime is 7 years.This device is 12 years old.If remedial action initiated , check type - this section is not applicable as no remedial action was initiated.If action reported to fda under 21 usc 360i (f), list correction / removal reporting number - this section is not applicable as there was no action reported under 21usc 360i(f).

Event Description

Smoke seen from leadpoint equipment.Occurred on (b)(6) 2019 @ 10:45am.No one was hurt or didn't cause any damage to any other unit."the machine was in use with a patient on (b)(6) 2019 @10;45.The smoke was coming from the back of the unit while it was in use.As soon as it happened, the machine was taken out.It's kept separately and not going to use on any patient.There are two serial no's on the back of the machine: (b)(4).We did not take any pictures at that point.As i had mentioned earlier i was scrubbed at the table and it was neurophysiology people who were doing the mer.".

Manufacturer Narrative

The system is over 12 years old, end of service/warranty is 7 years.There is no repair or replacement of parts option for this system, therefore the system cannot be repaired.The customer has been made aware of this.The customer has stated she does not know exactly were the smoke came from, the neuro physician thinks its from the amplifiers, she does not have any more explanation as she was scrubbed up and away from the machine.

Manufacturer Narrative

The device has not been returned by the customer to natus to allow for further investigation to be conducted, two documented requests have been made and although the customer noted that they could return the device it has not been returned over the last 3 months.Should we receive the device at a later stage an investigation will be conducted and appropriate regulatory bodies will be informed of the results.The customer did send photos of the device.No physical damage noted to the device from the photos received.The customer confirmed that there were no flames.

• Brand Name: DANTEC LEADPOINT WORKSTATION 5+3
• Type of Device: LEADPOINT WORKSTATION 5+3
• Manufacturer (Section D): ALPINE BIOMED APS; alpine biomed aps; skovlunde, DK-27 40; DA DK-2740
• MDR Report Key: 8353484
• MDR Text Key: 140452020
• Report Number: 3004827015-2019-00001
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• PMA/PMN Number: K140680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2019

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: 9031A051401
• Device Catalogue Number: 9031A051401
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 01/24/2019; 01/24/2019
• Supplement Dates FDA Received: 03/20/2019; 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other