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 Insufficient Information (4580)

Event Date 01/12/2022

Event Type  malfunction  

Event Description

Graphic controls (d/b/a nissha medical technologies/vermed/biomedical innovations) is the u.S.Agent and initial importer of products manufactured by nissha medical technologies sas registration number: (b)(4), a foreign manufacturer located in france ("nissha medical").On (b)(6) 2022 nissha medical notified graphic controls of a suspected failure of the claravue patient monitoring device family that transmit patient monitoring signals to third-party devices ("ip set") to perform to an established specification.Testing performed by a third-party potential customer related to product development identified that one 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.

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.

• 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
• MDR Report Key: 13509365
• MDR Text Key: 295143438
• Report Number: 1317188-2022-00004
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2022,02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/12/2022
• Event Location: Other
• Date Report to Manufacturer: 01/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1