FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE MX400 PATIENT MONITOR
MDR report key: 7167348
·
Received January 5, 2018
Report
- Report Number
- 9610816-2018-00004
- Event Type
- Malfunction
- Date Received
- January 5, 2018
- Report Date
- December 13, 2017
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K130849
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE MONITOR FROM THE RECOVERY ROOM AND OR IN THE EDH DOES NOT PASS ON ALARMS TO THE CONTROL CENTER. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE REPORTED INCIDENT. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED FOR THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10944 | INTELLIVUE MX400 PATIENT MONITOR | PATIENT MONITOR | MHX | PHILIPS MEDICAL SYSTEMS | 866060 (MX400) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |