FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE MP5
MDR report key: 3063473
·
Received March 28, 2013
Report
- Report Number
- 9610816-2013-00073
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Report Date
- March 13, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K091395
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER STATED THAT THE DEVICE SHOWED A SPEAKER MALFUNCTION INOP AND THERE WERE NO AUDIBLE ALARMS. 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 STATED THAT THE DEVICE SHOWED A SPEAKER MALFUNCTION INOP AND THERE WERE NO AUDIBLE ALARMS. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 129194 | INTELLIVUE MP5 | MHX | PHILIPS MEDICAL SYSTEMS | M8105A (865024) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |