FDA Adverse Event
Malfunction
Summary report: N
VS3: NBP, SPO2, TEMP
MDR report key: 2272525
·
Received September 21, 2011
Report
- Report Number
- 1218950-2011-02763
- Event Type
- Malfunction
- Date Received
- September 21, 2011
- Report Date
- August 30, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MHX
- PMA / PMN Number
- K082280
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE MONITOR WORKS PROPERLY, BUT AUDIO FAULT IS DISPLAYED. NO PT HARM WAS REPORTED. 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 THE MONITOR WORKS PROPERLY. BUT AUDIO FAULT IS DISPLAYED. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VS3: NBP, SPO2, TEMP | MHX | PHILIPS HEALTHCARE - ANDOVER | 863073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |