FDA Adverse Event
Malfunction
Summary report: N
MP70 INTELLIVUE PATIENT MONITOR
MDR report key: 2040049
·
Received March 25, 2011
Report
- Report Number
- 9610816-2011-00160
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Report Date
- March 2, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K021300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT CONFIGURATION SETTINGS OF THE PATIENT MONITOR HAD BEEN CHANGED WITHOUT USER INTERACTION. THE EXACT ALARM SETTING REFERED TO WITHIN THIS COMPLAINT IS UNKNOWN. IT WAS NOTED THAT THIS CITED ALARM SETTING WAS MANUALLY CHANGED TO THE DESIRED SETTING. THERE HAVE BEEN NO FURTHER REPORTS OF THIS ISSUE WITH THE CITED MONITOR. DEVICE LABELING (INSTRUCTIONS FOR USE) ADEQUATELY DESCRIBES MEASUREMENT SETTINGS. CONSIDERATION OF THIS COMPLAINT AND SIMILAR COMPLAINTS SUPPORTS THAT THERE IS NO DESIGN, MANUFACTURING, MATERIALS, OR LABELING PROBLEM. NO FURTHER ACTION OR INVESTIGATION IS WARRANTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT CONFIGURATION SETTINGS OF THE PATIENT MONITOR HAD BEEN CHANGED WITHOUT USER INTERACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MP70 INTELLIVUE PATIENT MONITOR | DSI | PHILIPS MEDICAL SYSTEMS | M8007A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |