FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE TELEMETERY SYSTEM
MDR report key: 3221613
·
Received July 1, 2013
Report
- Report Number
- 1218950-2013-02707
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Report Date
- May 7, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MHX
- PMA / PMN Number
- K041741
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
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
THE CUSTOMER REPORTED THAT THEY WERE EXPERIENCING TELEMETRY DROP OUTS IN NEWLY INSTALLED MX40'S CONNECTED TO PIIC IX. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297405 | INTELLIVUE TELEMETERY SYSTEM | MHX | PHILIPS MEDICAL SYSTEMS | M4840A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |