FDA Adverse Event
Malfunction
Summary report: N
MP70 INTELLIVUE PATIENT MONITOR
MDR report key: 2233109
·
Received July 22, 2011
Report
- Report Number
- 9610816-2011-00427
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Report Date
- July 19, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K021300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE MONITOR SHOULD HAVE ALARMED FOR HIGH PRIORITY ALARM BUT NO ALARM WAS REC'D. THE HOSPITAL BIOMEDICAL ENGINEER TESTED THE MONITOR AND IT PASSED ALL TESTING. NO PT HARM WAS REPORTED. PT HARM IS POSSIBLE SHOULD THE CLINICIAN NOT BE ALERTED TO A CHANGE IN THE PT STATUS OUTSIDE OF THE PRECONFIGURED PT PARAMETERS. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO REGARDING THIS INCIDENT 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 MONITOR SHOULD HAVE ALARMED FOR A HIGH PRIORITY ALARM BUT NO ALARM WAS REC'D. NO PT 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 |