FDA Adverse Event
Malfunction
Summary report: N
VS3: NBP, SP02, TEMP
MDR report key: 2091294
·
Received April 20, 2011
Report
- Report Number
- 1218950-2011-01049
- Event Type
- Malfunction
- Date Received
- April 20, 2011
- Report Date
- March 24, 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 TECHNICAL MESSAGE WAS DISPLAYED ON THE PATIENT MONITOR "SPEAKER MALFUNCTION" WITH NO AUDIO FUNCTION. ACCORDING TO THE CUSTOMER, THE SPEAKER WAS REPLACED INITIALLY AFTER FINDING THAT NO AUDIO WAS AVAILABLE FROM THE MONITOR. THIS REPLACEMENT DID NOT RESOLVE THE AUDIO ISSUE. THE CUSTOMER REPLACED THE MONITOR'S MAINBOARD, AND THE SPEAKER MALFUNCTION WAS RESOLVED. THE MONITOR WAS TESTED AND RETURNED TO USE WITHIN THE HOSPITAL. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A TECHNICAL MESSAGE WAS DISPLAYED ON THE PATIENT MONITOR "SPEAKER MALFUNCTION" AND THERE WAS NO AUDIO FUNCTION. NO PATIENT 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 |