MAUDE Adverse Event Report: ABBOTT MEDICAL VIEWMATE¿ Z ULTRASOUND CONSOLE WBATTERY ZS3; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	H701336
Medical Device Problem Codes	Sparking (2595); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During device preparation when powering up the viewmate ultrasound device, a sparking sound was heard and sparking was visible.The device would not power on.No patient was involved.
Additional Manufacturer Narrative
Additional information g3, g6, h2, h3, h6 the reported event was confirmed.Review of the provided fsr found the reported issue was resolved by replacing the battery.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 battery.

• Brand Name: VIEWMATE¿ Z ULTRASOUND CONSOLE WBATTERY ZS3
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23709117
• Report Number: 2184149-2025-00209
• Device Sequence Number: 16125255
• Product Code: IYN
• UDI-Device Identifier: 05415067013361
• UDI-Public: (01)05415067013361(10)6880869
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K151175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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
• Operator of Device: Health Professional
• Device Model Number: H701336
• Device Catalogue Number: H701336
• Device Lot Number: 6880869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown