INTELLIVUE MX800 PATIENT MONITOR
Report
- Report Number
- 9610816-2022-00436
- Event Type
- Malfunction
- Date Received
- August 17, 2022
- Date of Event
- August 1, 2022
- Manufacturer
- PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
- Product Code
- DSI
- UDI-DI
- 00884838020733
- PMA / PMN Number
- K150310
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION
A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
A FIELD SERVICE ENGINEER HAS BEEN SENT TO THE CUSTOMER SITE FOR DEVICE EVALUATION.
IT WAS REPORTED THAT THE INTELLIVUE MX800 PATIENT MONITOR DID NOT ALARM FOR A TACHYCARDIA FOR THE NEONATAL PATIENT IN ROOM 2446E ON (B)(6) 2022 AROUND 16:00. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.
IT WAS REPORTED THAT THE INTELLIVUE MX800 PATIENT MONITOR DID NOT ALARM FOR A TACHYCARDIA FOR THE NEONATAL PATIENT IN ROOM (B)(4) ON (B)(6) 2022 AROUND 16:00. A PHILIPS REMOTE SERVICE ENGINEER REVIEWED THE CLINICAL AUDIT TRAIL AND IDENTIFIED A TACHY ALARM WAS AT 4:42PM. A PHILIPS FIELD SERVICE ENGINEER (FSE) TESTED THE DEVICE AND FOUND THE DEVICE WAS OPERATING AS EXPECTED. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.
THIS ISSUE IS CONSIDERED NO LONGER REPORTABLE. THE INVESTIGATION DETERMINED THAT THE DEVICE ALARMED AS INTENDED AS DESCRIBED BELOW. THERE WAS NO DEVICE PROBLEM AND THE ISSUE IS ATTRIBUTED TO USER ERROR. IT WAS REPORTED THAT THE INTELLIVUE MX800 PATIENT MONITOR DID NOT ALARM FOR A TACHYCARDIA FOR THE NEONATAL PATIENT IN ROOM (B)(4) ON (B)(6) 2022 AROUND 16:00 HOURS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM. A PHILIPS REMOTE SERVICE ENGINEER REVIEWED THE CLINICAL AUDIT TRAIL AND IDENTIFIED A XTACHY 193>180 GENERATED ON (B)(6) 2022 16:42:59PM. THE ALARM ENDED AT 16:44PM. A PHILIPS FIELD SERVICE ENGINEER (FSE) FURTHER TESTED THE DEVICE AND FOUND THE DEVICE WAS OPERATING AS EXPECTED. THE FULL INVESTIGATION DETERMINED THAT THE DEVICE WAS OPERATING PER SPECIFICATIONS. IF THE ISSUE DOES NOT REPRESENT A MALFUNCTION BUT IS RELATED TO USER KNOWLEDGE OR APPLICATION RELATED ISSUES, PRODUCT LABELING DESCRIBES ALARM BEHAVIOR. ALARM REMINDERS AND LATCHING CONFIGURATIONS ARE PROVIDED BASED UPON CLINICIAN WORKFLOW AND PREFERENCE. THESE CONFIGURATIONS ARE SET BASED ON INPUTS PROVIDED BY THE CUSTOMER AT THE TIME OF SERVICING OR INSTALLATION. THE PRODUCT SHIPS WITH A FACTORY DEFAULT CONFIGURATION WHICH HAS BEEN REVIEWED BY PRODUCT AND CLINICAL EXPERTS AND DETERMINED TO BE SAFE FOR USE. DURING INTERACTION WITH THE DEVICE, THE CUSTOMER WILL NOTICE SETTINGS THAT MAY NOT BE AS EXPECTED AT WHICH TIME THE USER CAN CUSTOMIZE THE SETTINGS THEMSELVES UNTIL USER DEFAULTS THAT ARE CUSTOMER-SPECIFIC CAN BE CONFIGURED, TROUBLESHOOT THE DEVICE, AND/OR IMPLEMENT ALTERNATIVE MEANS OF MONITORING IF WARRANTED.
IT WAS REPORTED THAT THE INTELLIVUE MX800 PATIENT MONITOR DID NOT ALARM FOR A TACHYCARDIA FOR THE NEONATAL PATIENT IN ROOM (B)(6) ON (B)(6) 2022 AROUND 16:00. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1221410 | INTELLIVUE MX800 PATIENT MONITOR | INTELLIVUE MX800 PATIENT MONITOR | DSI | PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH | 865240 | 00884838020733 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |