FDA Adverse Event
Malfunction
Summary report: N
MP70 INTELLIVUE PATIENT MONITOR
MDR report key: 2121549
·
Received May 6, 2011
Report
- Report Number
- 9610816-2011-00239
- Event Type
- Malfunction
- Date Received
- May 6, 2011
- Report Date
- April 6, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K021300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE CUSTOMER REPORTED THAT A BEDSIDE MONITOR DID NOT REPORT AN ALARM FROM ANOTHER BEDSIDE MONITOR WITHIN ITS CAREGROUP AS IT WAS EXPECTED. NO PATIENT 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 A BEDSIDE MONITOR DID NOT REPORT AN ALARM FROM ANOTHER BEDSIDE MONITOR WITHIN ITS CAREGROUP AS IT WAS CONFIGURED. 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 |