MAUDE Adverse Event Report: NATUS NEUROLOGY INCORPORATED EDX AMPLIFIER HOLDER & ARM,

Model Number 515-018500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Laceration(s) (1946); Not Applicable (3189)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

The user was switching out the pre-amps when the spring loaded c-arm went into extension, when the user removed the pre-amp the c-arm stuck her right between the eyes.The user obtained a small laceration and may have had a concussion as the user experienced some memory problems for a while.No medical intervention needed.Product examination and functional testing: additional information and safety guide is made available to the customer.In the guide, there is a warning about the spring in the amp arm.Per additional information and safety reference guide, page - 15, section - amplifier arm, line - ag-01, "take care when removing the amplifier arm tie wrap.The amplifier arm is spring-loaded and may snap open causing injury.Part number 515-018500 was pulled from stock for review of warning or caution labels on the device.The actual device does not have a warning label.However, there is one on the outside of the box.Customer warning label on the box of part number 515-018500, edx amplifier holder & arm.Per the warning it states, "this product contain a spring loaded arm for balance.It has been folded in half for packaging purposes.Care must be taken when the arm is moved from its package to avoid damage or injury.When folding the arm we recommended installing it in its provided bracket or base or other mounting option.Then carefully remove all plastic, tape and other packaging material.Make sure that no one is facing the front of the arm during unfolding." risk management file review: per information found in doc-013953 rev 17 emg-iom risk analysis file, hazard id - 6.6., hazard - cart tips or event causes accessories to come loose and fall onto or strike the user or patient, severity - 3, residual risk acceptable.

Event Description

The user was injured by the force of the c-arm spring when switching out amplifiers.The user obtained a small laceration and may have had a concussion.No medical intervention was needed.

Manufacturer Narrative

Update 19 aug 2020 (ref complaint number # (b)(4)).Investigation and findings: product will not be returned for evaluation as it did not malfunction.Customer warning label and additional information and safety guide were reviewed.In the guide, there is a warning about the spring in the amp arm.A risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probably of occurrence has not changed.Device history review/ service record review is not applicable as the product did not malfunction.There are no capa's related to this issue and this complaint does not identify a deficiency in the product design therefore a capa is not required.Per (b)(4) complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.No complaint trends have been identified complaint verified, isolated incident and monitor for future occurrence.

Event Description

The user was injured by the force of the c-arm spring when switching out amplifiers.The user obtained a small laceration and may have had a concussion.No medical intervention was needed.

• Brand Name: EDX AMPLIFIER HOLDER & ARM,
• Type of Device: EDX AMPLIFIER HOLDER & ARM,
• Manufacturer (Section D): NATUS NEUROLOGY INCORPORATED; 3150 pleasant view road; middleton 53562, wi
• MDR Report Key: 10302871
• MDR Text Key: 199899315
• Report Number: 3010611950-2020-00012
• Device Sequence Number: 1
• Product Code: GWQ
• Combination Product (y/n): N
• PMA/PMN Number: K180290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 515-018500
• Device Catalogue Number: 515-018500
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 68