FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE MX800 PATIENT MONITOR
MDR report key: 7918586
·
Received September 28, 2018
Report
- Report Number
- 9610816-2018-00246
- Event Type
- Malfunction
- Date Received
- September 28, 2018
- Report Date
- July 19, 2018
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- UDI-DI
- 00884838020733
- PMA / PMN Number
- K102562
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS A SPEAKER MALFUNCTION. A PHILIPS RESPONSE CENTER ENGINEER (RCE) VERIFIED WITH CUSTOMER BIOMED THAT THERE WAS NO SOUND FROM THE SPEAKER; THE VOLUME WAS INCREASED, BUT STILL NO SOUND. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 758266 | INTELLIVUE MX800 PATIENT MONITOR | INTELLIVUE MX800 PATIENT MONITOR | MHX | PHILIPS MEDICAL SYSTEMS | 865240 (MX800) | 00884838020733 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |