INFINITY ACUTE CARE SYSTEM (M540)
Report
- Report Number
- 1220063-2024-00070
- Event Type
- Malfunction
- Date Received
- June 28, 2024
- Date of Event
- July 22, 2023
- Report Date
- April 17, 2025
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC.
- Product Code
- MHX
- PMA / PMN Number
- K113798
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
FOLLOW-UP 2 REPORT 30SEPT.2024 - THIS CORRECTION IS TO UPDATE THE PRODUCT CODE FROM MQM TO MHX. FOLLOW-UP 1 REPORT 23AUG.2024: IT WAS REPORTED TO DRAEGER THAT A PATIENT MONITORING DEVICE DID NOT ALARM FOR ST ELEVATIONS, BUT THE STAFF WAS AT THE BEDSIDE AND WITNESSED THE ST ELEVATION. NO ADVERSE PATIENT IMPACT WAS REPORTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, NO INFORMATION WAS RECEIVED. THE INSTRUCTIONS FOR USE (IFU) FOR MONITORING APPLICATIONS OUTLINES THAT ALARM LIMITS CAN BE SET BY THE USER DETERMINING HOW LONG AN ALARM CONDITION MUST BE PRESENT BEFORE AN ALARM WILL BE GENERATED. IT IS UNCLEAR IF THIS CONTRIBUTED TO THE EVENT AND DUE TO THE LACK OF INFORMATION, NO ROOT CAUSE COULD BE DETERMINED. SYMPHONY IS AN APPLICATION FOR REVIEWING STORED DATA. IT PROVIDES A RETROSPECTIVE ANALYSIS OF PATIENT INFORMATION. REAL-TIME PATIENT MONITORING IS NOT INTERRUPTED.
UPDATED EVALUATION RESULTS: MORE INFORMATION WAS RECEIVED INCLUDING PICTURES OF THE ALARM SETTINGS USED AT THE CUSTOMER SITE. SCREENSHOTS OBTAINED DURING A TRAINING AT THE SITE WITH THE CHARGE NURSE SHOW ALL ST ALARM SETTINGS ARE SET TO OFF, WHICH IS THE USER PREFERENCE. THERE WAS NO DEVICE MALFUNCTION.
IT WAS REPORTED TO DRAEGER THAT A PATIENT MONITORING DEVICE DID NOT ALARM FOR ST ELEVATIONS, BUT THE STAFF WAS AT THE BEDSIDE AND WITNESSED THE ST ELEVATION. NO ADVERSE PATIENT IMPACT WAS REPORTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, NO INFORMATION WAS RECEIVED. THE INSTRUCTIONS FOR USE (IFU) FOR MONITORING APPLICATIONS OUTLINES THAT ALARM LIMITS CAN BE SET BY THE USER DETERMINING HOW LONG AN ALARM CONDITION MUST BE PRESENT BEFORE AN ALARM WILL BE GENERATED. IT IS UNCLEAR IF THIS CONTRIBUTED TO THE EVENT AND DUE TO THE LACK OF INFORMATION, NO ROOT CAUSE COULD BE DETERMINED. SYMPHONY IS AN APPLICATION FOR REVIEWING STORED DATA. IT PROVIDES A RETROSPECTIVE ANALYSIS OF PATIENT INFORMATION. REAL-TIME PATIENT MONITORING IS NOT INTERRUPTED.
THE CUSTOMER REPORTED THAT THE PATIENT MONITORING DEVICE DID NOT ALARM FOR ST ELEVATIONS. THE STAFF WAS BEDSIDE AND WITNESSED THE ST ELEVATION. A DOCTOR WAS CALLED IN FOR ACTION TO BE TAKEN. FURTHER DETAILS REGARDING PATIENT TREATMENT WERE NOT PROVIDED. THE CUSTOMER CONFIRMED NO ADVERSE PATIENT IMPACT.
THE CUSTOMER REPORTED THAT THE PATIENT MONITORING DEVICE DID NOT ALARM FOR ST ELEVATIONS. THE STAFF WAS BEDSIDE AND WITNESSED THE ST ELEVATION. A DOCTOR WAS CALLED IN FOR ACTION TO BE TAKEN. FURTHER DETAILS REGARDING PATIENT TREATMENT WERE NOT PROVIDED. THE CUSTOMER CONFIRMED NO ADVERSE PATIENT IMPACT.
THE CUSTOMER REPORTED THAT THE PATIENT MONITORING DEVICE DID NOT ALARM FOR ST ELEVATIONS. THE STAFF WAS BEDSIDE AND WITNESSED THE ST ELEVATION. A DOCTOR WAS CALLED IN FOR ACTION TO BE TAKEN. FURTHER DETAILS REGARDING PATIENT TREATMENT WERE NOT PROVIDED. THE CUSTOMER CONFIRMED NO ADVERSE PATIENT IMPACT.
THE CUSTOMER REPORTED THAT THE PATIENT MONITORING DEVICE DID NOT ALARM FOR ST ELEVATIONS. THE STAFF WAS BEDSIDE AND WITNESSED THE ST ELEVATION. A DOCTOR WAS CALLED IN FOR ACTION TO BE TAKEN. FURTHER DETAILS REGARDING PATIENT TREATMENT WERE NOT PROVIDED. THE CUSTOMER CONFIRMED NO ADVERSE PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1387899 | INFINITY ACUTE CARE SYSTEM (M540) | PHYSIOLOGIC MONITORING SYSTEM | MHX | DRAEGER MEDICAL SYSTEMS, INC. | |||
| 828845 | INFINITY ACUTE CARE SYSTEM (M540) | PHYSIOLOGIC MONITORING SYSTEM | MHX | DRAEGER MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |