DPM6
Received Feb 18, 2026 · Event occurred Jan 20, 2026
Report 2221819-2026-00003 · MDR key 24380686
Device
Product problems
- Date/Time-Related Software Problem
Patient
NA · Female
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
THE CUSTOMER REQUESTED A REVIEW OF THE DEVICE LOGS AND A COMPLETE RETRIEVAL OF ALL AVAILABLE DATA RECORDED ON THE DATE OF THE REPORTED EVENT OR THE MOST RECENT STORED ENTRIES FROM MINDRAY DPM 6 PATIENT MONITOR (SERIAL NUMBER (B)(6)). IT WAS REPORTED THAT PATIENT EXPERIENCED A CODE EVENT AND WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER HOSPITAL, WHERE THE CUSTOMER'S BIOMEDICAL ENGINEER BELIEVED THE PATIENT WAS DECLARED BRAIN DEAD. IN ADDITION, THE CUSTOMER INDICATED THAT THE MONITOR DISPLAYED AN INCORRECT TIME AND DATE DURING THE REPORTED EVENT. THE CLINICAL EVENT WAS REPORTED TO HAVE OCCURRED BETWEEN APPROXIMATELY 08:30 AND 09:45 ON (B)(6) 2026; HOWEVER, THE DPM 6 MONITOR HAD THE TIMESTAMP OF (B)(6) 2006 AT 01:11.
Additional Manufacturer Narrative
THE UNIT WAS RETURNED AND ELECTRONIC DATA WAS COLLECTED. INVESTIGATION OF THE DEVICE DID NOT IDENTIFY ANY MALFUNCTION. REVIEW OF PATIENT DATA INDICATES THAT THE DEVICE CONTINUED TO MONITOR AND GENERATE ALARMS AS INTENDED DURING THE REPORTED TIMEFRAME. THE DISCREPANCY IN THE DISPLAYED DATE AND TIME IS SUSPECTED TO BE ASSOCIATED WITH DEPLETION OF THE CMOS BATTERY, WHICH MAY HAVE CAUSED A SYSTEM CLOCK RESET. BECAUSE DEVICE LOG FILES COULD NOT BE OBTAINED AND THE INFORMATION PROVIDED WAS LIMITED, NO ADDITIONAL DETAILS COULD BE INVESTIGATED.
Additional Manufacturer Narrative
THE UNIT WAS RETURNED AND ELECTRONIC DATA WAS COLLECTED. UNDER INVESTIGATION.
Description of Event or Problem
THE CUSTOMER REQUESTED A REVIEW OF THE DEVICE LOGS AND A COMPLETE RETRIEVAL OF ALL AVAILABLE DATA RECORDED ON THE DATE OF THE REPORTED EVENT OR THE MOST RECENT STORED ENTRIES FROM MINDRAY DPM 6 PATIENT MONITOR (SERIAL NUMBER (B)(6). IT WAS REPORTED THAT PATIENT EXPERIENCED A CODE EVENT AND WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER HOSPITAL, WHERE THE CUSTOMER'S BIOMEDICAL ENGINEER BELIEVED THE PATIENT WAS DECLARED BRAIN DEAD. IN ADDITION, THE CUSTOMER INDICATED THAT THE MONITOR DISPLAYED AN INCORRECT TIME AND DATE DURING THE REPORTED EVENT. THE CLINICAL EVENT WAS REPORTED TO HAVE OCCURRED BETWEEN APPROXIMATELY 08:30 AND 09:45 ON JANUARY 20, 2026; HOWEVER, THE DPM 6 MONITOR HAD THE TIMESTAMP OF (B)(6) 2006 AT 01:11.