MAUDE Adverse Event Report: ZONARE MEDICAL SYSTEMS, INC VIEWMATE ZS3 ARM NEW (4TH EDITION); SYSTEM, SIGNAL ISOLATION

Model Number H701336

Device Problem Smoking (1585)

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

Event Date 10/04/2022

Event Type  malfunction  

Event Description

During the procedure, with the patient on the table, the system started smoking.

Manufacturer Narrative

Review of the provided fsr found the reported issue was resolved by replacing the power supply.The device history record was completed by a representative from mindray.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received and the investigation performed, the cause of the reported event was isolated to the power supply.

• Brand Name: VIEWMATE ZS3 ARM NEW (4TH EDITION)
• Type of Device: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ZONARE MEDICAL SYSTEMS, INC; 420 north bernardo avenue; mountain view CA 94043
• Manufacturer (Section G): ZONARE MEDICAL SYSTEMS, INC; 420 north bernardo avenue; mountain view CA 94043
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15544909
• MDR Text Key: 303247554
• Report Number: 3004189859-2022-00003
• Device Sequence Number: 1
• Product Code: DRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H701336
• Device Catalogue Number: H701336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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