FDA Adverse Event
Death
Summary report: N
M3155 RELEASE L.0. UPGRADE
MDR report key: 3670459
·
Received February 20, 2014
Report
- Report Number
- 1218950-2014-00772
- Event Type
- Death
- Date Received
- February 20, 2014
- Date of Event
- February 10, 2014
- Report Date
- February 12, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K062271
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE RHYTHM DISPLAYED ON THE MONITOR DID NOT CONSISTENTLY MATCH THE PT CONDITION AND NOT ALL ALARMS WERE PROVIDED OR HEARD. THE PT, WHO HAD CARDIAC RHYTHM DISTURBANCES, DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106424 | M3155 RELEASE L.0. UPGRADE | MHX | PHILIPS MEDICAL SYSTEMS | M3155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Death |