Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.
- Recall Initiated
- July 27, 2015
- Posted
- September 4, 2015
- Terminated
- May 2, 2017
- Recall Number
- Z-2737-2015
- Quantity
- 13 units
- Firm Location
- Mahwah, NJ
Reason for Recall
The DPM 7 Monitors may display a black screen.
Distribution
Distributed to the states of CT, IA, KY, MS, PA, UT and WA.
Lot / Code Info
Lot #14A18, PN: 6800F-PA00001, Serial Numbers: DU- 46002583, DU-46002587, DU-46002588, DU-46002589, DU-46002592, DU-46002594, DU-46002595, DU-46002596, DU-46002599, DU-46002600, DU-46002601, DU-46002605 and DU-46002606
Root Cause
Under Investigation by firm
Action Taken
Mindray sent an Urgent Medical Device Correction / DPM 7 Monitor letter, dated July 27, 2015, to their affected customers via certified mail and return receipt. The letter identified the problem as well as the affected product, adverse effects on patients, and corrective action. The firm will repair the potentially affected monitor at no cost to the customer. Customers are to contact their Mindray Service Representative at 1-800-288-2121 to arrange for the repair.