FDA Adverse Event
Malfunction
Summary report: N
SURESIGNS VS3 PT MONITOR
MDR report key: 2070496
·
Received March 29, 2011
Report
- Report Number
- 1218950-2011-00790
- Event Type
- Malfunction
- Date Received
- March 29, 2011
- Report Date
- March 7, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MHX
- PMA / PMN Number
- K082280
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE AUDIBLE ALARM ON THE MONITOR WAS NOT WORKING. THE INITIAL INVESTIGATION SUPPORTS THAT THIS WAS A SPEAKER FAILURE. 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 REPORTED THAT THE AUDIBLE ALARM ON THE MONITOR WAS NOT WORKING. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURESIGNS VS3 PT MONITOR | MHX | PHILIPS HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |