FDA Adverse Event
Injury
Summary report: N
INTELLIVUE MULTI MEASUREMENT SERVER X2
MDR report key: 1902574
·
Received November 12, 2010
Report
- Report Number
- 9610816-2010-00739
- Event Type
- Injury
- Date Received
- November 12, 2010
- Date of Event
- November 3, 2010
- Report Date
- November 7, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K071426
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE AN EXPECTED ECG RED ALARM. THEY RECEIVED A DIFFERENT ALARM. THE PATIENT NEEDED TO BE REANIMATED. THE PATIENT'S ECG SIGNAL WAS REPORTED AS VERY SMALL, INDICATING INADEQUATE LEADS PLACEMENT OR CONTACT. THE MONITOR PASSED ALL TESTING AFTER THIS REPORT. 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 THEY DID NOT RECEIVE AN EXPECTED ECG RED ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELLIVUE MULTI MEASUREMENT SERVER X2 | MHX | PHILIPS MEDICAL SYSTEMS | M3002A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |