MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED ERGOJUST DESKTOP CART- ACCESSORY TO EEG MEDICAL DEVICES

Model Number IP-EC-DT-CART

Device Problems Use of Device Problem (1670); Material Integrity Problem (2978)

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

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

Initial report (b)(6) 2020.(reference complaint# (b)(4)) investigation results and findings: per our risk analysis spreadsheet doc (b)(4) rev.36 - hazard id: 6:11 with the initial risk = 9, risk acceptable = yes.Residual risk = 9, residual risk acceptable = yes.Risk benefit analysis id -04, rating = low.No new risks introduced by control measures.Product has been requested and will be returned for evaluation.

Event Description

The customer reported the pole on a cart snapped and the employee was injured on the hand.The device was not been used for patient care when the event occurred.

Event Description

The customer reported the pole on a cart snapped and the employee was injured on the hand.The device was not been used for patient care when the event occurred.

Manufacturer Narrative

Follow up report 001 08th october 2020 (reference complaint# (b)(4)).Investigation results and findings: the employee noticed a screw came out near the bottom of the pole and was trying to determine its size for replacement.The pole snapped, bent over.At this time of manufacturer, these carts did not contain serial numbers, natus has since added serial numbers.The cart was returned to natus and evaluated by natus' mechanical engineer: the mast was returned and observed that both welds that hold the inner portion of the mast to the cross member had failed.The welds broke away from the thinner metal of the upper mast before the thicker metal of the cross member.There was significant deformation of the cross member on one side of the mast indicating that one weld failed first and the other weld was supporting the mast until it also broke.It takes a significant amount of force to cause this type of bending of the cross member.This could be caused by misuse this mast version is the initial design that did not have the additional back-up features in case of weld failure.The root cause determined the weld failure was due to misuse.Risk assessment (b)(4), hazard line item 6.11: hazard: due to mechanical stress or impact, dynamic loading, vibration, or environmental conditions -- accessory shelf on cart may be unable to support the mass of accessories or items placed on its surface, causing it to bend or break and leave sharp edges exposed or broken support system could land on and harm someone.Hazard content: system.Effects: range from clinically insignificant to irreversible injury resulting from direct physical injury.Severity: 3.Pohs: 4.Phslh: 2.Pooh: 3.Initial risk: 9.Risk acceptable: yes.Control measures: 1a.Design control device designed in compliance to iec60601-1 mechanical strength requirements (section 15) testing with tensile safety factor 4x.2.Protective measures/ manufacturing process: not possible to reduce risk further using protective measures/manufacturing processes.3.Information for safety.Control measures implemented: 1.Ergojust ltm cart, ergojust icu cart: (b)(4): preq-140, preq-144.2.N/a.3.Ergojust ltm cart, ergojust icu cart: (b)(4): preq-164.Verification and effectiveness of control measure: 1.V&v note (ar).2.N/a.3.User and service manuals: transportation warnings: v&v note (aq).V&v note (bg).Residual pohs: 1; residual phslh: 2; residual pooh: 1; residual risk: 3; residual risk: acceptable.Benefit risk rationale: rba-04: the hazards identified have been evaluated and found to be in compliance with a known standard.As noted in qms-000018, hazards that have been evaluated and found to be in compliance with known standards can be presumed to be consistent with an acceptable level of risk, yielding an acceptable risk / benefit to the patient or user.Risk outweighed by benefit of use of device.New risks introduced: no new risks introduced by control measures.Status: ok.

• Brand Name: ERGOJUST DESKTOP CART- ACCESSORY TO EEG MEDICAL DEVICES
• Type of Device: ERGOJUST DESKTOP CART- ACCESSORY TO EEG MEDICAL DEVICES
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd. (xltex); 2568 bristol circle; oakville, ontarios,l6h 5s1, ; CA
• MDR Report Key: 10391124
• MDR Text Key: 205010968
• Report Number: 9612330-2020-00007
• Device Sequence Number: 1
• Product Code: GWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1