InjuryMSX
MINDRAY
Received Dec 23, 2019 · Event occurred Dec 19, 2019
Report MW5091875 · MDR key 9516702
Device
Generic name
System Network And Communication, Physiological Monitors
Manufacturer
Mindray Ds Usa Inc.Product problems
- Computer Software Problem
Patient
65 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
MINDRAY TELEMETRY CANNOT DETECT PACEMAKER SPIKES RELIABLY. MONDAY¿S SOLUTION IS TO DISABLE PACEMAKER DETECTION IN THEIR SOFTWARE. THIS PUTS PATIENTS AT RISK OCCURRING AT ALL FACILITIES THAT USE MINDRAY. FDA SAFETY REPORT ID # (B)(4).