INTELLISPACE PERINATAL ADV SYS, INTEG ED
Report
- Report Number
- 9610816-2023-00322
- Event Type
- Malfunction
- Date Received
- July 5, 2023
- Date of Event
- June 12, 2023
- Manufacturer
- PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
- Product Code
- HGM
- PMA / PMN Number
- K100420
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO EVALUATE THE DEVICE AND CONFIRMED THE SYSTEM GOT AN ALARM MESSAGE ¿NO ALARMING FOR THE BED X ¿. THE FSE ROOT CAUSE OF THE ISSUE IS THE DAC SERVER. THE ISSUE WAS RESOLVED WITH A REBOOT, BUT IT APPEARS THE ISSUE COMES BACK INTERMITTENTLY ON A RANDOM BED. THE FSE CONFIRMED THE ISSUE WAS RESOLVED WITH A SYSTEM REBOOT AND THE UNIT IS NOW WORKING AS INTENDED. THE FSE WILL BE MONITORING THE ISSUE REMOTELY. IF FURTHER INFORMATION IS OBTAINED THIS COMPLAINT WILL BE REOPENED.
THE CUSTOMER REPORTED IT DOES NOT ALARM IN DECELERATING EVENTS. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.
THE CUSTOMER REPORTED IT DOES NOT ALARM IN DECELERATING EVENTS. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 418001 | INTELLISPACE PERINATAL ADV SYS, INTEG ED | INTELLISPACE PERINATAL ADV SYS, INTEG ED | HGM | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH | 866132 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |