MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS¿ SUCTION ELECTRODE FOR KISS¿ SYSTEM; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Catalog Number 21732801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Tissue Damage (2104)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

Vyaire complaint number: (b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire has not received the suspect device/component for evaluation.

Event Description

A customer contacted vyaire medical to inform that a patient reportedly suffered from permanent damage to the skin during or after use of the suction electrode.At this time, the customer has not provided any additional information.

• Brand Name: VITAL SIGNS¿ SUCTION ELECTRODE FOR KISS¿ SYSTEM
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): MSC TECHNOLOGIES SYSTEMS GMBH; munzingerstrasse 3; freiburg, 79111 ; GM 79111
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 9440894
• MDR Text Key: 170482380
• Report Number: 3006638842-2019-00001
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21732801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability