FDA Adverse Event
Malfunction
Summary report: N
HUDSON OPTI-NEB PRO COMPRESSOR W/ DISP. NEB.
MDR report key: 3113863
·
Received May 7, 2013
Report
- Report Number
- 1044475-2013-00057
- Event Type
- Malfunction
- Date Received
- May 7, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 16, 2013
- Manufacturer
- TELEFLEX
- Product Code
- CAF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE DEVICE BLEW OUT WHITE POWDER LIKE FLAKES UPON TURNING ON THE UNIT. THE ALLEGED INCIDENT OCCURRED PRIOR TO USE. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 198045 | HUDSON OPTI-NEB PRO COMPRESSOR W/ DISP. NEB. | COMPRESSOR NEBULIZER SYSTEM | CAF | TELEFLEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |