SHP UNT INFINITY M540
Report
- Report Number
- 1220063-2025-00048
- Event Type
- Injury
- Date Received
- August 19, 2025
- Report Date
- September 24, 2025
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC
- Product Code
- MHX
- PMA / PMN Number
- K113798
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE INVESTIGATION HAS STARTED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION.
MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER TO SUPPORT A ROOT CAUSE ANALYSIS. HOWEVER, NO DETAILS REGARDING THE PATIENT OUTCOME OR LONG-TERM IMPACT WERE PROVIDED. ADDITIONALLY, ESSENTIAL DATA INCLUDING SYSTEM LOGS, ELECTROCARDIOGRAM WAVEFORM REPORTS, AND ARRHYTHMIA ALARM SETTINGS WERE NOT MADE AVAILABLE. DUE TO THE LACK OF SUPPORTING INFORMATION, THE REPORTED ISSUE COULD NOT BE CONFIRMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. IF FURTHER INFORMATION BECOMES AVAILABLE, THE COMPLAINT MAY BE REOPENED FOR CONTINUED INVESTIGATION.
IT WAS REPORTED THAT A PATIENT WAS FOUND UNCONSCIOUS WITH BRADYCARDIA RHYTHM BUT THE INFINITY M540 PATIENT MONITOR DID NOT PROVIDE AN ALARM. THE BRADYCARDIA WAS DETECTED BY VISUAL OBSERVATION FROM THE INFINITY CENTRAL STATION (ICS). NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT A PATIENT WAS FOUND UNCONSCIOUS WITH BRADYCARDIA RHYTHM BUT THE INFINITY M540 PATIENT MONITOR DID NOT PROVIDE AN ALARM. THE BRADYCARDIA WAS DETECTED BY VISUAL OBSERVATION FROM THE INFINITY CENTRAL STATION (ICS). NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1395076 | SHP UNT INFINITY M540 | PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT | MHX | DRAEGER MEDICAL SYSTEMS, INC | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |