FDA Adverse Event
Death
Summary report: N
TELEMETRY TRANSMITTER
MDR report key: 1691817
·
Received May 12, 2010
Report
- Report Number
- 1218950-2010-00697
- Event Type
- Death
- Date Received
- May 12, 2010
- Report Date
- May 6, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K961165
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT UPON A PT INCIDENT, THE TELEMETRY DID NOT ALERT A RED ALARM. THE INITIAL REPORT FROM THE CUSTOMER INDICATES THAT THE MONITORING WAS UNRELATED TO THE PT DEATH. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS INCIDENT AND THE COMPLAINT REMAINS UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. (B) (4)
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT UPON A PT INCIDENT, THE TELEMETRY DID NOT ALERT A RED ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELEMETRY TRANSMITTER | DSI | PHILIPS MEDICAL SYSTEMS | M2601B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |