FDA Adverse Event
Death
Summary report: N
PANORAMA CENTRAL STATION
MDR report key: 3093849
·
Received May 1, 2013
Report
- Report Number
- 2221819-2013-00551
- Event Type
- Death
- Date Received
- May 1, 2013
- Date of Event
- March 13, 2013
- Report Date
- April 30, 2013
- Manufacturer
- MONDRAY DS USA, INC.
- Product Code
- MHX
- PMA / PMN Number
- 031760
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DOCUMENTATION FROM THE EVENT WERE COLLECTED. A REVIEW OF THE WAVEFORM DATA CONFIRMS THAT THE PANORAMA SYSTEM OPERATED WITHIN SPECIFICATIONS. THE REPORTED EVENT DID NOT EXCEED THE ESTABLISHED THRESHOLD TO INITIATE A CALL OF VENTRICULAR FIBRILLATION.
Description of Event or Problem · 1
CUSTOMER REPORTED A PATIENT EXPIRED WHILE BEING MONITORED ON THE PANORAMA CENTRAL STATION WITH AMBULATORY TELEPACK, AND THE CENTRAL STATION DID NOT PRODUCE AN ALARM FOR A VENTRICULAR FIBRILLATION AND ASYSTOLE EVENTS, INSTEAD IT ALARMED FOR A LOW HEART RATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 188865 | PANORAMA CENTRAL STATION | CENTRAL MONITORING STATION | MHX | MONDRAY DS USA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |