VITAL SYNC REMOTE MONITORING SYSTEM
Received Jan 24, 2022 · Event occurred Jan 7, 2022
Report 1717344-2022-00079 · MDR key 13333156
Device
Generic name
Transmitters And Receivers, Physiological Sign
Manufacturer
Covidien Mfg Dc BoulderModel number
10116080Catalog number
10116080
Product problems
- Computer Software Problem
- Computer Software Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE REMOTE SURVEILLANCE SYSTEM WAS NOT ALARMING. MULTIPLE DEVICES ON DIFFERENT FLOORS WERE NOT ALARMING. THERE WERE NO ERRORS WITH THE REMOTE SURVEILLANCE SYSTEM, AND THE DATA COLLECTION SERVER WAS RESTARTED. IT WAS FOUND THAT THE ISSUE WAS TIED UP TO THE HEALTHCARE DATA INTEGRATION ENGINE. IT GENERATED AN ADDITIONAL LINE ITEM AND CAUSED THE ALARMS NOT TO PROCESS. A LINE ITEM WAS ADDED TO HEALTHCARE DATA INTEGRATION ENGINE WHICH REMOVED THE ADDITIONAL LINE THAT CAME FROM THE THIRD PARTY SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.