FDA Adverse Event
Malfunction
Summary report: N
PHILLIPS TELEMETRY PAK
MDR report key: 3193451
·
Received June 21, 2013
Report
- Report Number
- MW5030667
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Report Date
- June 21, 2013
- Manufacturer
- PHILLIPS HEALTHCARE
- Product Code
- DSI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WV, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
TELEMETRY PAKS NOT TRANSFERRING THE PT WAVE FORM. PROBLEM IS OCCURRING WITH MULTIPLE PACKS OF THE SAME SYSTEM ON THE SAME FLOOR BUT NOT AT THE SAME TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281843 | PHILLIPS TELEMETRY PAK | TELEMETRY PAK | DSI | PHILLIPS HEALTHCARE | MX40-1B4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |