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

Model Number Z.ONE ULTRASOUND SYSTEM

Device Problems Device Operational Issue (2914); Improper Device Output (2953)

Patient Problem No Code Available (3191)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

The unit was tested and no malfunction was identified.The device was confirmed to operate according to specifications.Data provided by the user was analyzed and the data input was confirmed to have generated the expected outcome measurements.(b)(4).

Event Description

A customer reported birth was included based on the fetal weight measurement (5lb).Actual birth weight was confirmed to be (b)(6).No patient (mother or baby) injury or complication were reported.

Manufacturer Narrative

Correct typo on event: included should read induced.

Event Description

A customer reported birth was induced based on the fetal weight measurement (5lb).Actual birth weight was confirmed to be 6lb 5oz.No patient (mother or baby) injury or complication were reported.

• Brand Name: Z.ONE ULTRASOUND SYSTEM
• Type of Device: ULTRASOUND SYSTEM
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; buildings 9-13, baiwangxin; high-tech industrial park; baimang, xili town, nanshan, 51810 8; CH 518108
• MDR Report Key: 7441898
• MDR Text Key: 105871295
• Report Number: 3009156722-2018-00003
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K171891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/18/2018,03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z.ONE ULTRASOUND SYSTEM
• Device Catalogue Number: 82001M-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2018
• Date Manufacturer Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRANSDUCER C8-3 3D
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 59