FDA confronts Mindray over patient monitor quality control
Regulators cited China's largest medical device company in a Nov. 29 warning letter for a number of quality system violations. Among the allegations:
Mindray replaced at least 17 units of its V-Series monitors with touch screens at the end of 2011 and through mid-2012 that failed to work, disabling the interface. What's more, the FDA said, the company hadn't taken any effort to make corrections or evaluate the actions that suppliers took to initially fix the problem.
The company failed to conduct sufficient investigations regarding a number of failed monitor modules and faulty software.
Company managers fell short in establishing procedures to handle complaints regarding device, labeling or packaging failures, and also in how they put together reports documenting those problems.
The warning letter isn't Mindray's only run-in with the FDA over quality problems. In the fall, the company enacted a voluntary recall of its A3/A5 Anesthesia Delivery System, warning that the devices could possibly leak CO2.
Mindray's manufacturing erupted as the company has pursued a number of acquisitions to grow. At the same time, however, Mindray is struggling to keep growing its North American revenue even as its market share increases.
- read the FDA warning letter