MAUDE Adverse Event Report: CLAVIS EMG/STIM DEVICE

Model Number 9015A0012

Device Problem Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

Initial report (ref natus complaint #1: (b)(4)).Part 9015a0012 clavis emg/stim device: there is a loud foreground sound when used, it gives maximum rash throughout, which then makes it impossible to use as a guide for intramuscular botulinum toxin injections.It has been tested with electrodes of another model to exclude faulty electrodes without improvement.It can suddenly become unusable from one stick to another.It then becomes, as described, a loud sound with character as if it were a round in a regular speaker sometimes and as if the equipment gives maximum response sometimes.Both noises make it impossible to use them as injection guidance, which becomes directly patient-hazardous.Product has been requested for evaluation.

Event Description

Clavis: noise/ sound issues.No patient injury.

Manufacturer Narrative

Follow up report 001 (ref natus complaint # (b)(4)).The device have been requested back for investigation.The device has not been returned yet.Capa and complaint trending review: as per qms-004442 (corporate trending and analysis procedure, rev.C), complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.A review of the complaint trending completed as part of the quarterly corporate data analysis in q3, 2020 (ref: (b)(4)) and also as part of the gort monthly complaints trending (ref: (b)(4)) was carried out.Risk management file: a review of the risk document, ((b)(4)) has been completed and risk identified as 5.13 {component failure or design error causing poor, noisy or missing emg sound output} with a severity of 0 assigned.Risk therefore is determined as low.A further 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 probability of occurrence has not changed a device history record review is not needed as the device is over years old and the failure is not attributed to a manufacturing defect.

Event Description

Clavis - noise/sound issues.No patient injury.

Manufacturer Narrative

Follow up report (b)(4).(ref natus complaint #(b)(4)).We have received very little information regarding this event, the sound frequency for this was not recorded so therefore we do not know the level the customer is reporting.The customer has not responded to any communications and also to any of our requests for more information.The devices have been requested back for investigation.No response or devices has been received from the customer.A device history record review is not needed as the devices are over (b)(4) years old and the failure is not attributed to a manufacturing defect.A search for service data that may have been relevant to this issue was conducted.No further information related to this issue was found.Investigation result code: neuro sbu|sound issue.Closure rationale:complaint could not be verified, monitor for future occurrence.

Event Description

Clavis - noise/ sound issues.No patient injury.

• Brand Name: CLAVIS EMG/STIM DEVICE
• Type of Device: CLAVIS EMG/STIM DEVICE
• MDR Report Key: 11568825
• MDR Text Key: 242236269
• Report Number: 3005581270-2021-00004
• Device Sequence Number: 1
• Product Code: BXN
• UDI-Device Identifier: 00382830049702
• UDI-Public: 00382830049702
• Combination Product (y/n): N
• PMA/PMN Number: K062478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9015A0012
• Device Catalogue Number: 9015A0012
• Device Lot Number: 1112/5094
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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