MAUDE Adverse Event Report: NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK) ERGO JUST CART- ACCESSORY TO EEG MEDICAL DEVICES; ELECTROENCEPHALOGRAPH

Model Number IP-EC-DT-CART

Device Problems Use of Device Problem (1670); Misassembly by Users (3133)

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

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

In compliance with 21cfr part820.198 - quality system regulations and natus quality management system, we initiated the investigation of the reported failure.The cause of the problem identified as deficiency in following the instruction.Customer installed a heavier monitor on the cart without adjusting the spring tension as explained in the user manual provided with the cart.Customer has been informed to adjust the tension if non-natus supplied monitor to use.

Event Description

Ergojust desktop cart - the adjustable work surface on the cart collapsed and hit someone on the knee causing brief pain on impact.The defective cart was taken out of use.

• Brand Name: ERGO JUST CART- ACCESSORY TO EEG MEDICAL DEVICES
• Type of Device: ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK); 2568 bristol circle; oakville, oakville ontario L6H 5 S1; CA L6H 5S1
• Manufacturer (Section G): NATUS MEDICAL INCORPORATED DBA EXCEL-TECH (XLTEK); 2568 bristol circle; oakville, ontario L6H5S 1; CA L6H5S1
• Manufacturer Contact: sanjay mehta ; 2568 bristol circle; oakville, ontario L6H5S-1 ; CA L6H5S1
• MDR Report Key: 7861895
• MDR Text Key: 119930593
• Report Number: 9612330-2018-00006
• Device Sequence Number: 1
• Product Code: GWQ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IP-EC-DT-CART
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1