PIC IX HARDWARE
Report
- Report Number
- 1218950-2022-00111
- Event Type
- Death
- Date Received
- February 8, 2022
- Date of Event
- January 12, 2022
- Manufacturer
- PHILIPS NORTH AMERICA LLC
- Product Code
- MHX
- PMA / PMN Number
- K102495
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER. THE CALL WAS TRANSFERRED TO A PHILIPS REMOTE CLINICAL SPECIALIST (RCS). THE CUSTOMER INFORMED THAT RCS THAT WHAT THEY WOULD LIKE PHILIPS TO ASSIST WITH REVIEWING THE AUDIT LOG AND GENERAL REVIEW FULL DISCLOSURE WITH THEM AS WELL AS PULL OTHER LOGS. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND RETRIEVED THE CLINICAL AUDIT LOGS, THE TECHNICAL LOG AND WAVE STRIPS. A PHILIPS CLINICAL SOLUTIONS IMPLEMENTATION CONSULTANT WENT ONSITE TO FURTHER REVIEW THE AUDIT LOG WITH THE CUSTOMER. THE LOGS WERE REVIEWED BY A PHILIPS CLINICAL PRODUCT SPECIALIST (CPS). IN ORDER FOR AN ALARM TO LOG IN THE PIC IX AUDIT LOG, THE ALARM HAS TO HAVE OCCURRED AT THE PIC IX. THE AUDIT LOG SHOWS THAT A YELLOW LOW SPO2 ALARMED AT 14:12:17 FOLLOWED BY A RED DESAT ALARM AT 14:12:28, WHICH WAS SILENCED AT 14:13:02 AND ENDED AT 14:15:05. AN ADDITIONAL RED DESAT ALARM WAS TRIGGERED AT 14:15:24 AND REMINDED AT 14:16:02. THE ALARM WAS SILENCED AT 14:16:54 AND ENDED THE ALARM. THERE WAS NO PRODUCT MALFUNCTION; THIS IS CONSIDERED A USER ISSUE. BASED ON PHILIPS¿ INVESTIGATION, THE LOGS INDICATE THAT THERE WERE INOPS FOR SPO2 AND A RED ALARM FOR DESAT THAT WERE SILENCED AT THE PIC IX SURVEILLANCE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.
THE CUSTOMER BIOMEDICAL ENGINEER REPORTED THAT AN MX40 PAIRED WITH AN MP5. A DESATURATION ALARM SOUNDED ON THE MP5 BUT NOT AT THE PATIENT INFORMATION CENTER IX (PIC IX ) OR AT THE OVERVIEW AS REPORTED BY STAFF. THE DEVICE WAS IN USE AT THE TIME OF EVENT, A DEATH WAS REPORTED.
THE CUSTOMER BIOMEDICAL ENGINEER REPORTED THAT AN MX40 PAIRED WITH AN MP5. A DESATURATION ALARM SOUNDED ON THE MP5 BUT NOT AT THE PATIENT INFORMATION CENTER IX (PIC IX ) OR AT THE OVERVIEW AS REPORTED BY STAFF. THE DEVICE WAS IN USE AT THE TIME OF EVENT, A DEATH WAS REPORTED.
THE CUSTOMER BIOMEDICAL ENGINEER REPORTED THAT AN MX40 PAIRED WITH AN MP5. A DESATURATION ALARM SOUNDED ON THE MP5 BUT NOT AT THE PATIENT INFORMATION CENTER IX (PIC IX ) OR AT THE OVERVIEW AS REPORTED BY STAFF. THE DEVICE WAS IN USE AT THE TIME OF EVENT, A DEATH WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 903638 | PIC IX HARDWARE | PIC IX HARDWARE | MHX | PHILIPS NORTH AMERICA LLC | 866424 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Death |