FDA Adverse Event
Malfunction
Summary report: N
VS3 MONITOR W/NIBP
MDR report key: 2220155
·
Received August 8, 2011
Report
- Report Number
- 1218950-2011-02121
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Report Date
- July 12, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MHX
- PMA / PMN Number
- K052707
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE REPORTED DESCRIPTION OF THE COMPLAINT NOTES THERE WAS A PT MONITOR SPEAKER MALFUNCTION MESSAGE ON THE DISPLAY SCREEN. WE WILL CONSIDER THAT, FOR THIS MODEL AND SERIAL NUMBER, RECURRENCE OF THIS FAILURE MODE COULD INCLUDE LOSS OF AUDIO AND POSSIBLE HEALTH RISK. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO 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 THAT THERE WAS A PT MONITOR SPEAKER MALFUNCTION MESSAGE ON THE DISPLAY SCREEN. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VS3 MONITOR W/NIBP | MHX | PHILIPS HEALTHCARE - ANDOVER | 863069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |