MAUDE Adverse Event Report: ZONARE MEDICAL SYSTEMS, INC VIEWMATE¿ Z ULTRASOUND CONSOLE WBATTERY ZS3; SYSTEM, SIGNAL ISOLATION

Model Number H701336

Device Problem Signal Artifact/Noise (1036)

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

Event Date 05/11/2023

Event Type  malfunction  

Event Description

During the atrial fibrillation procedure, noise was noted on the image of viewmate z ultrasound console resulting in a delay.The viewmate z scan engine and non-abbott ice catheter (acunav) had no noise.The location of the power supply was changed, the viewmate catheter interface module was exchanged, and an isolation transformer was used without resolution.This issue was noted when the viewmate z ultrasound console was used at another location.The issue was partially resolved by decreasing the frequency on the ice side from 6mhz to 5mhz.The gain was also decreased, but the issue persisted.Decreasing the dr made the noise worse.The power supply was unplugged, and the noise that displayed to the center was then reduced, but it had no effect on the noise that appeared in oblique concentric circles.The procedure was completed without replacing the device and there were no adverse consequences to the patient.The procedure was delayed about 45 minutes.

Manufacturer Narrative

Review of the provided fsr found the results of the investigation are inconclusive as the device was not returned for analysis.The device history record review 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, the cause of the reported incident could not be determined.

• Brand Name: VIEWMATE¿ Z ULTRASOUND CONSOLE WBATTERY ZS3
• 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: 17107918
• MDR Text Key: 316977765
• Report Number: 3004189859-2023-00001
• Device Sequence Number: 1
• Product Code: DRJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

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: Health Professional
• Device Model Number: H701336
• Device Catalogue Number: H701336
• Device Lot Number: 6567373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2018
• 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