INFINITY ACUTE CARE SYSTEM (M540)
Report
- Report Number
- 1220063-2024-00098
- Event Type
- Injury
- Date Received
- August 7, 2024
- Date of Event
- July 27, 2024
- Report Date
- November 12, 2024
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC
- Product Code
- MHX
- UDI-DI
- 04049098009799
- PMA / PMN Number
- K113798
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A COMPLAINT WAS SUBMITTED WHERE IT WAS REPORTED THAT IACS MONITOR (M540) CONTINUED TO GO INTO STANDBY MODE DURING PATIENT PREPARATION FOR ANESTHESIA. THE USER ATTEMPTED TO REPLACE THE M540 BUT THE 'STANDBY' PROBLEM PERSISTED. A NEW ANESTHETIC CART WITH NEW MONITORING EQUIPMENT WAS USED TO CONTINUE THE CASE WHICH WAS SUCCESSFUL WITHOUT ANY FURTHER ISSUES. THERE WAS NO ADVERSE EFFECT TO THE PATIENT AS A RESULT OF REPLACING THE NEW MONITORING EQUIPMENT. DRAEGER TECHNICAL SUPPORT ANALYZED THE LOGS AND CONFIRMED THAT THE M540 WENT INTO 'STANDBY' MODE PERIODICALLY, BUT IT WAS VERY INTERMITTENT. THIS WAS COMMUNICATED TO THE BIOMED AT THE CUSTOMER'S SITE WHERE HE PERFORMED AN EVALUATION ON THE SUSPECTED M540. THE BIOMED CONFIRMED THAT THE 'STANDBY' BUTTON COULD BE ACTIVATED BY PRESSING THE M540 BEZEL CASE ADJACENT TO THE 'STANDBY' KEY. THE M540 BEZEL CASE WAS REPLACED, AND THE DEVICE RAN FOR SEVERAL HOURS WITH NO FAILURES FOUND. THE ROOT CAUSE OF THE M540 ISSUE WAS DETERMINED TO BE A DAMAGED BEZEL CASE. REPLACING THE OLD CASE WITH A NEW ONE RESOLVED THE REPORTED ISSUE. NO FURTHER PROBLEMS HAVE BEEN REPORTED.
THE INITIAL UDI AND SERIAL NUMBER FOR THE REPORTED DEVICE WAS INCORRECT. THIS FOLLOW UP IS TO CORRECT THAT INFORMATION, AND DOES NOT SUPPLY ANY ADDITIONAL INVESTIGATION RESULTS AT THE TIME OF THIS SUBMISSION.
THE CUSTOMER REPORTED THAT THE MONITOR KEPT GOING INTO STAND-BY MODE WHILE MONITORING THE PATIENT WHILE THE PATIENT WAS BEING PREPPER FOR ANESTHESIA. THE COMPLAINT FORM STATES THAT "THE PATIENT WAS ON THE TABLE AND HAD TO BE BAGGED", AND ALSO STATED NO REPORTED INJURY. NO PATIENT DEATH REPORTED.
THE CUSTOMER REPORTED THAT THE MONITOR KEPT GOING INTO STAND-BY MODE WHILE MONITORING THE PATIENT WHILE THE PATIENT WAS BEING PREPPER FOR ANESTHESIA. THE COMPLAINT FORM STATES THAT "THE PATIENT WAS ON THE TABLE AND HAD TO BE BAGGED", AND ALSO STATED NO REPORTED INJURY. NO PATIENT DEATH REPORTED.
THE CUSTOMER REPORTED THAT THE MONITOR KEPT GOING INTO STAND-BY MODE WHILE MONITORING THE PATIENT WHILE THE PATIENT WAS BEING PREPPER FOR ANESTHESIA. THE COMPLAINT FORM STATES THAT "THE PATIENT WAS ON THE TABLE AND HAD TO BE BAGGED", AND ALSO STATED NO REPORTED INJURY. NO PATIENT DEATH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264556 | INFINITY ACUTE CARE SYSTEM (M540) | PHYSIOLOGIC MONITORING SYSTEM | MHX | DRAEGER MEDICAL SYSTEMS, INC | 04049098009799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |