FDA Adverse Event
Death
Summary report: N
MP30 INTELLIVUE PT MONITOR
MDR report key: 4192722
·
Received October 8, 2014
Report
- Report Number
- 9610816-2014-00256
- Event Type
- Death
- Date Received
- October 8, 2014
- Date of Event
- September 27, 2014
- Report Date
- September 29, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K030038
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO CONCERNING THIS EVENT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED "THE NURSE HEARD AND SAW NO ALARM FROM (B)(6). EXPECTED WAS AN ASYSTOLE ALARM. ON HALF PAST SIX AM THE NURSE WAS IN THE ROOM. AN "ECG LEADS OFF" WAS RECOGNIZED. ACCORDING TO THE NURSE THE PT WAS FINE AND THE LEADS WERE REATTACHED. BRIEFLY AFTER 7 AM ANOTHER NURSE FOUND THE PT UNRESPONDING IN THE ROOM. THE PT WAS DECEASED"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 633053 | MP30 INTELLIVUE PT MONITOR | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | PHILIPS MEDICAL SYSTEMS | M8002A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |