BENEVISION N12 PATIENT MONITOR
Received Jul 7, 2026 · Event occurred Jun 6, 2026
Report 2221819-2026-00008 · MDR key 25732686
Device
Product problems
- Low Readings
Patient
Not reported
- Low Oxygen Saturation
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT ON (B)(6) 2026, A NICU PATIENT ON NON-INVASIVE VENTILATION HAD SPO2 VALUES ON A BENEVISION N12 MONITOR (SERIAL NUMBER (B)(6)) THAT APPEARED INCONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION. INITIAL SPO2 ALARM WAS 88% AT 18:12, DECREASED TO 86% DESPITE INCREASED FIO2, AND LATER DECLINED TO 80% WITH "POOR PLETH" AT 18:53 AND 58% AT 19:08. THE PATIENT WAS REPORTEDLY PINK, WARM, AWAKE, MOVING, AND CRYING. A PORTABLE BENEVISION N12 (SERIAL NUMBER (B)(6)) INTERMITTENTLY DISPLAYED SPO2 VALUES IN THE 90S. WHEN RETURNED TO THE ORIGINAL MONITOR (SERIAL NUMBER (B)(6)) AT 19:19, SPO2 WAS 52%, SPO2 PR WAS 43 BPM, AND ECG HR WAS 191 BPM. HEALTHCARE PROFESSIONALS CHECKED THE CORD AND CHANGED ELECTRODES. THE PATIENT WAS INTUBATED AT 20:00, NOTED TO BE DETERIORATING AND CLINICALLY "ILL APPEARING" AT 20:30, THEN CODED AT 23:05, AND WAS PRONOUNCED DECEASED AT 23:26.
Additional Manufacturer Narrative
ELECTRONIC DATA HAS BEEN COLLECTED AND IS CURRENTLY BEING INVESTIGATED BY THE MANUFACTURER AND SPO2 SENSOR SUPPLIER.
Description of Event or Problem
The customer reported that on (b)(6) 2026, a NICU patient on non-invasive ventilation had SpO2 values on a BeneVision N12 monitor (serial number (b)(6)) that appeared inconsistent with the patient's clinical presentation. Initial SpO2 alarm was 88% at 18:12, decreased to 86% despite increased FiO2, and later declined to 80% with "poor pleth" at 18:53 and 58% at 19:08. The patient was reportedly pink, warm, awake, moving, and crying. A portable BeneVision N12 (serial number (b)(6)) intermittently displayed SpO2 values in the 90s. When returned to the original monitor (serial number (b)(6)) at 19:19, SpO2 was 52%, SpO2 PR was 43 bpm, and ECG HR was 191 bpm. Healthcare professionals checked the cord and changed electrodes. The patient was intubated at 20:00, noted to be deteriorating and clinically "ill appearing" at 20:30, then coded at 23:05, and was pronounced deceased at 23:26.
Additional Manufacturer Narrative
The electronic data review remains under investigation by the manufacturer and the SpO2 sensor supplier. Mindray performed testing on the BeneVision N12 monitor using accessories similar to those reported during the event, as the accessories used at the time of the occurrence were not available for evaluation. Based on the testing performed, the BeneVision N12 operated within specification.