FDA Adverse Event
Malfunction
Summary report: N
VS3: NBP, SP02, TEMP
MDR report key: 2121403
·
Received May 5, 2011
Report
- Report Number
- 1218950-2011-01161
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Report Date
- April 14, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MHX
- PMA / PMN Number
- K082280
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE REPORTED DESCRIPTION NOTES THAT A MALFUNCTION ERROR MESSAGE WAS DISPLAYED ON THE PT MONITOR AND THE AUDIO (FUNCTION) FAILED. NO PT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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 REPORTED DESCRIPTION NOTES THAT A MALFUNCTION ERROR MESSAGE WAS DISPLAYED ON THE PT MONITOR AND THE AUDIO (FUNCTION) FAILED. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VS3: NBP, SP02, TEMP | MHX | PHILIPS HEALTHCARE | 863073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |