FDA Adverse Event
Malfunction
Summary report: N
MP 50 INTELLIVUE PATIENT MONITOR
MDR report key: 1953925
·
Received December 15, 2010
Report
- Report Number
- 9610816-2010-00811
- Event Type
- Malfunction
- Date Received
- December 15, 2010
- Report Date
- November 19, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K030038
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT THE BESIDE MONITOR DID NOT PROVIDE AN ALARM TO THE CAREGROUPING IN THE BED OVERVIEW AS THE NURSE EXPECTED. NO PATIENT HARM WAS REPORTED. TESTING OF THE MONITORING SYSTEM ON SITE BY THE HOSPITAL'S BIOMED SHOWED THAT ALL MONITORING COMPONENTS ARE WORKING AS INTENDED. THE USER PROBLEM WAS DUE TO A MISUNDERSTANDING OF WHAT SETTINGS HAD BEEN CONFIGURED BY THE USERS. NO FURTHER ASSISTANCE WAS REQUESTED. THE DEVICE LABELING (INSTRUCTIONS FOR USE) ADEQUATELY DESCRIBES CAREGROUP ALARMING. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR DID NOT PROVIDE AN ALARM TO THE CAREGROUPING IN THE BED OVERVIEW AS THE NURSE EXPECTED. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MP 50 INTELLIVUE PATIENT MONITOR | MHX | PHILIPS MEDICAL SYSTEMS | M8004A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |