FDA Adverse Event
Death
Summary report: N
PHILIPS TELEMON
MDR report key: 2111676
·
Received May 27, 2011
Report
- Report Number
- 1218950-2011-01470
- Event Type
- Death
- Date Received
- May 27, 2011
- Date of Event
- April 28, 2011
- Report Date
- May 3, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- DSI
- PMA / PMN Number
- K011824
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED WHILE THE PATIENT WAS BEING MONITORED ON A TELEMETRY TRANSMITTER, CONNECTED TO A TELEMON BEDSIDE MONITOR. THE CUSTOMER WANTED TO KNOW IF THE TELEMETRY TRANSMITTER CONTRIBUTED TO THE DEATH OF THE PATIENT AS THEY WERE NOT SURE IF THE EQUIPMENT WORKED. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE DEVICE WAS WORKING AS INTENDED. IN ABUNDANT CAUTION, WE WILL REPORT THIS FAILURE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED WHILE THE PATIENT WAS BEING MONITORED ON A TELEMETRY TRANSMITTER, CONNECTED TO A TELEMON BEDSIDE MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHILIPS TELEMON | DSI | PHILIPS HEALTHCARE | M2636B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |