FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE MX500 PATIENT MONITOR
MDR report key: 8280811
·
Received January 28, 2019
Report
- Report Number
- 9610816-2019-00025
- Event Type
- Malfunction
- Date Received
- January 28, 2019
- Report Date
- January 23, 2019
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- UDI-DI
- 00884838038776
- PMA / PMN Number
- K131872
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 0
SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED BY THE ICN STAFF; THE MONITOR DID NOT ALARM OR PRODUCE SOUND AT A CRITICAL MOMENT. THIS WAS REPORTED TO HAVE OCCURRED FROM THE EVENING OF (B)(6) 2019, AROUND 3:00AM. IT SHOULD HAVE BEEN A RED BRADY ALARM. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73523 | INTELLIVUE MX500 PATIENT MONITOR | PATIENT MONITOR | MHX | PHILIPS MEDICAL SYSTEMS | 866064 | 00884838038776 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |