FDA Adverse Event
Malfunction
Summary report: N
MP70 INTELLIVUE PATIENT MONITOR
MDR report key: 2102561
·
Received May 19, 2011
Report
- Report Number
- 9610816-2011-00240
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Report Date
- April 28, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K021300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT AN SPO2 ALARM WAS NOT GENERATED WHEN A PATIENT'S SPO2 FELL OUTSIDE OF THE LIMITS. NO PATIENT HARM WAS REPORTED. THE LIMITED INFORMATION PROVIDED DOES NOT SUPPORT THAT THERE WAS ANY MALFUNCTION. 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 AN SPO2 ALARM WAS NOT GENERATED WHEN A PATIENT'S SPO2 FELL OUTSIDE OF THE LIMITS. NO PATIENT HARM WAS REPORTED.
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 |