FDA Adverse Event
Malfunction
Summary report: N
SPACELABS DIGITAL TELEMETRY TRANSMITTER
MDR report key: 2082675
·
Received April 28, 2011
Report
- Report Number
- 3023361-2011-00014
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 27, 2011
- Manufacturer
- SPACELABS HEALTHCARE
- Product Code
- DSI
- PMA / PMN Number
- K925510
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SPACELABS RECEIVED THE AFFECTED PRODUCTS ON (B)(4) 2011. THE INVESTIGATION IS UNDERWAY. THERE IS NOT SUFFICIENT DATA TO IDENTIFY THE ROOT CAUSE AT THIS TIME. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION. WE WILL PROVIDE A SUPPLEMENTAL REPORT ONCE OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT SPACELABS TELEMETRY TRANSMITTER CHANNEL 1039 SHOWED UP ON CHANNEL 1103.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPACELABS DIGITAL TELEMETRY TRANSMITTER | TELEMETRY TRANSMITTER | DSI | SPACELABS HEALTHCARE | 91341-09 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |