FDA Adverse Event
Injury
Summary report: N
MP70 INTELLIVUE PATIENT MONITOR
MDR report key: 1882357
·
Received October 22, 2010
Report
- Report Number
- 9610816-2010-00613
- Event Type
- Injury
- Date Received
- October 22, 2010
- Date of Event
- October 12, 2010
- Report Date
- October 12, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K021300
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT DURING A PT CODE, THEY WERE UNSURE IF THE MONITOR GENERATED AN SPO2 ALARM. BASED ON THE AVAILABLE INFO, IT IS UNCLEAR IF THE ALARM WAS SILENCED OR IF IT DID NOT GENERATE. THE CUSTOMER HAS REQUESTED THAT PHILIPS REVIEW THE SYSTEM LOGS FOR DETAILED INFO. 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 DURING A PT CODE, THEY WERE UNSURE IF THE MONITOR GENERATED AN SPO2 ALARM OR WHETHER A CLINICIAN HAD ACKNOWLEDGED THE ALARM.
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 |