INFINITY ACUTE CARE SYSTEM (M540)
Report
- Report Number
- 1220063-2017-00060
- Event Type
- Injury
- Date Received
- November 21, 2017
- Date of Event
- November 15, 2017
- Report Date
- January 8, 2018
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC
- Product Code
- CBK
- PMA / PMN Number
- K113798
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
AFTER REVIEWING THE LOGS FROM THE EVENT, IT WAS FOUND THAT AN ASYSTOLE ALARM GENERATED DURING THE EVENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY BY A DRAEGER SERVICE TECHNICIAN AND IT WAS FOUND THAT ASYSTOLE GENERATED BOTH AUDIBLY AND VISUALLY CORRECTLY. THERE WAS NO FAILURE WITH THE DEVICE. OUR DEVICE COULD BE EXCLUDED FROM THE PATIENT EVENT.
THE INVESTIGATION HAS BEEN STARTED BUT NOT YET CONCLUDED. THE RESULT WILL BE PUBLISHED IN THE FOLLOW UP REPORT.
IT WAS REPORTED THAT DURING PATIENT MONITORING, THE IACS DID NOT ALARM FOR ASYSTOLE AND THE PATIENT HAD TO BE RESUSCITATED. THE PATIENT SURVIVED. THE HOSPITAL'S MEDICAL ENGINEER TESTED THE MONITOR AND THE CENTRAL MONITORING SYSTEM WITH A PATIENT SIMULATOR AND BOTH AUDIBLE AND VISUAL ALARMS WERE GIVEN. THE MEDICAL ENGINEER ASSUMES THIS WAS DUE TO A USER ERROR.
IT WAS REPORTED THAT DURING PATIENT MONITORING, THE IACS DID NOT ALARM FOR ASYSTOLE AND THE PATIENT HAD TO BE RESUSCITATED. THE PATIENT SURVIVED. THE HOSPITAL'S MEDICAL ENGINEER TESTED THE MONITOR AND THE CENTRAL MONITORING SYSTEM WITH A PATIENT SIMULATOR AND BOTH AUDIBLE AND VISUAL ALARMS WERE GIVEN. THE MEDICAL ENGINEER ASSUMES THIS WAS DUE TO A USER ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 830434 | INFINITY ACUTE CARE SYSTEM (M540) | PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT | CBK | DRAEGER MEDICAL SYSTEMS, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |