MAUDE Adverse Event Report: NISSHA MEDICAL TECHNOLOGIES SAS CLARAVUE; PRE- WIRED ELECTRODE

Model Number 50401-US;50600-US;50601- US;50602-US;50603-US;50604- US

Device Problems Electrical /Electronic Property Problem (1198); Defibrillation/Stimulation Problem (1573)

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

Event Date 07/21/2021

Event Type  malfunction  

Event Description

Nissha medical technologies sas registration number: (b)(4).A foreign manufacturer located in france ("nissha medical sas") identified a failure of the claravue patient monitoring device family that transmits patient monitoring signals to third-party devices ("ip set") to perform to an established specification.Testing performed internally and by a third-party potential customer related to product development identified that one portion of the ip set product did not perform in compliance with specifications outlined in ansi/aami ec53:2013/ (r)2020 ecg trunk cables and patient leadwires.Specifically, the product did not meet section 5.3.9 *dielectric withstand voltage, which requires the assembly to withstand, without breakdown, an application of 5,000 v d.C.The product labeling (instructions for use) indicates compliance with the ec53 standard.Compliance with the standard is not required if the product is labeled "not defibrillation proof" in accordance with the labeling requirements provided in section 5.1.5 of the standard; however, the products do not contain such labeling.There have been no reports of adverse events or injuries related to the malfunction.Additionally, there have been no reports of the malfunction by any end users in the field.Attached is a technical analysis of the malfunction prepared by graphic controls dba nissha medical technologies/vermed/biomedical innovations.Note: this report being compiled and submitted by: graphic controls dba nissha medical technologies/vermed/biomedical innovations, the u.S.Agent.

Manufacturer Narrative

Full product list for us: 32028776 50401-us ip-set n3 - pediatric-us; 32028777 50600-us ip set m3 rt adult-us; 32028778 50601-us ip set m5 rt adult-us; 32028779 50602-us ip set 12 rt adult-us; 32028780 50603-us ip set 6v rt adult-us; 32028781 50604-us ip set 5v rt adult-us.7/21/2021 internal testing was performed following an indication from a third-party potential customer related to their own product development.

• Brand Name: CLARAVUE
• Type of Device: PRE- WIRED ELECTRODE
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES SAS; 23-25 boulevard de la paix; cergy val-d'oise 95800 ; FR 95800
• Manufacturer (Section G): GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES/V; 400 exchange street; buffalo NY 14204
• Manufacturer Contact: jessica potter ; 23-25 boulevard de la pai; cergy val-d'oise 95800 ; FR 95800
• MDR Report Key: 13534122
• MDR Text Key: 296374945
• Report Number: 3004762958-2022-00001
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 02/14/2022

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: Other
• Device Model Number: 50401-US;50600-US;50601- US;50602-US;50603-US;50604- US
• Device Catalogue Number: MULTIPLE
• Device Lot Number: ALL LOTS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1