FDA Adverse Event
Malfunction
Summary report: N
MP30 INTELLIVUE PATIENT MONITOR
MDR report key: 2140588
·
Received June 16, 2011
Report
- Report Number
- 9610816-2011-00343
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Report Date
- June 10, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K030038
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED RECEIVING A "SPEAKER MALFUNCTION" ERROR MESSAGE FOR A NON-FUNCTIONAL SPEAKER ON A BEDSIDE MONITOR. NO PT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED RECEIVING A "SPEAKER MALFUNCTION" ERROR MESSAGE FOR A NON-FUNCTIONAL SPEAKER ON A BEDSIDE MONITOR. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MP30 INTELLIVUE PATIENT MONITOR | MHX | PHILIPS MEDICAL SYSTEMS | M8002A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |