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

Model Number	H701336
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.Further information was requested but not received.
Event or Problem Description
During the procedure, the transducer could not be selected, a black screen was noted and the case was cancelled.There were no consequences to the patient and the case was rescheduled.
Additional Manufacturer Narrative
Analysis of the returned logs confirmed the reported event of the transducer not being selected and a black screen being noted.Results of the investigation determined the cause of the malfunction was the module.The module evaluation indicated the power board needed to be replaced.The device history record (dhr) for the unit involved in the report was reviewed, no issues were noted.Based on the information provided to abbott and the investigation performed, the cause for the reported event was due to the power board.

• Brand Name: VIEWMATE Z ULTRASOUND CONSOLE WBATTERY ZS3
• Common Device Name: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ZONARE MEDICAL SYSTEMS, INC; 420 north bernardo avenue; mountain view CA 94043
• MDR Report Key: 10437235
• Report Number: 3004189859-2020-00004
• Device Sequence Number: 19570341
• Product Code: DRJ
• UDI-Device Identifier: 05415067013361
• UDI-Public: 05415067013361
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H701336
• Device Catalogue Number: H701336
• Device Lot Number: 6047587
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other