FDA Adverse Event
Death
Summary report: N
MP20 INTELLIVUE PATIENT MONITOR
MDR report key: 4250079
·
Received November 7, 2014
Report
- Report Number
- 9610816-2014-00292
- Event Type
- Death
- Date Received
- November 7, 2014
- Date of Event
- October 10, 2014
- Report Date
- October 28, 2014
- Manufacturer
- AGILENT TECHNOLOGIES DEUTSCHLAND
- 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
IT WAS REPORTED THAT THE POLICE THOUGHT A PT IN ONE OF THE BEDS CUT THE MONITORING CABLE OF ANOTHER PATIENT WHICH THEN LED TO THE DEATH OF THE PT. THE EQUIPMENT DID NOT MALFUNCTION BUT THE PT WAS NOT MONITORED FOR A TIME, WHICH COULD HAVE CONTRIBUTED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 719333 | MP20 INTELLIVUE PATIENT MONITOR | COMPACT PATIENT MONITOR | MHX | AGILENT TECHNOLOGIES DEUTSCHLAND | M8001A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |