MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Z.ONE PRO ULTRASOUND SYSTEM

Model Number Z.ONE PRO ULTRASOUND SYSTEM

Device Problems Power Problem (3010); Complete Loss of Power (4015)

Patient Problem Perforation of Vessels (2135)

Event Date 05/15/2022

Event Type  Injury  

Manufacturer Narrative

The facilities biomedical representative cleaned the systems main module and reported significant dust accumulation, and replaced the battery.The representative indicated the battery was installed (b)(6) 2021 and estimated to ~18 months old.It was also reported that it is the facilities common practices to leave ultrasound system in a constant "on" state which may have led to the system overheating.The representative recommended to the facility to keep the unit off and connected to ac power.Mindray continues to pursue good faith efforts to obtain information regarding the patient outcome as well as photographs of the battery.System logs have been obtained and are under evaluation.

Event Description

Customer reported the ultrasound system shutdown while installing a central line, the doctor lost visibility and the patient's artery was nicked.The patient outcome has not been provided by the device user.The system was running on battery power.

Manufacturer Narrative

Customer provided noticed on june 30, 2022 and modified the date of occurrence ((b)(6) 2022 at 7:36), thus form 3500 fields b.3 and b.5 are updated.The reported issue could not be confirmed based on system log review.Customer reported that after battery replacement no other issues were noted.

Event Description

Customer reported the on (b)(6) 2022, at 19:36 (7:36 pm) the ultrasound system shutdown while installing a central line, the doctor lost visibility and the patient's artery was nicked.The patient outcome has not been provided by the device user.The system was running on battery power.

• Brand Name: Z.ONE PRO ULTRASOUND SYSTEM
• Type of Device: Z.ONE PRO ULTRASOUND SYSTEM
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guangming 51810 6; CH 518106
• MDR Report Key: 14843384
• MDR Text Key: 294864724
• Report Number: 2221819-2022-00013
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/13/2022,08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z.ONE PRO ULTRASOUND SYSTEM
• Device Catalogue Number: Z034-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female