FDA Adverse Event
Death
Summary report: N
MP60 INTELLIVUE PATIENT MONITOR
MDR report key: 5041926
·
Received August 31, 2015
Report
- Report Number
- 9610816-2015-00191
- Event Type
- Death
- Date Received
- August 31, 2015
- Date of Event
- August 17, 2015
- Report Date
- August 18, 2015
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K030038
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. (B)(4).
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE DID NOT ALARM FOR A VTACH ON (B)(6) 2015 AT AROUND 5 PM. THE PATIENT PASSED AWAY ON (B)(6) 2015.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE DID NOT ALARM FOR A VTACH ON (B)(6) 2015 AT AROUND 5 PM. THE PATIENT PASSED AWAY ON (B)(6) 2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 574462 | MP60 INTELLIVUE PATIENT MONITOR | COMPACT PATIENT MONITOR | MHX | PHILIPS MEDICAL SYSTEMS | M8005A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |