FDA Adverse Event
Other
Summary report: N
MINIELITE COMPRESSOR NEBULIZER SYSTEM
MDR report key: 2625718
·
Received December 23, 2009
Report
- Report Number
- 2243193-2009-00002
- Event Type
- Other
- Date Received
- December 23, 2009
- Date of Event
- December 11, 2009
- Report Date
- December 23, 2009
- Manufacturer
- RESPIRONICS NEW JERSEY, INC.
- Product Code
- CAF
- PMA / PMN Number
- K060404
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NO BEEN RECEIVED FROM THE PATIENT FOR INVESTIGATION, THEREFORE, AT THIS TIME, IT IS NOT POSSIBLE TO DETERMINE IF THE DEVICE IS THE ROOT CAUSE FOR THE PATIENT NEEDING TO GO TO THE EMERGENCY ROOM FOR TREATMENT. COMPRESSOR NEBULIZER SYSTEMS ARE NOT CONSIDERED LIFE-SUSTAINING DEVICE NAD NO PERMANENT HARM WAS REPORTED AS THE PATIENT WAS TREATED AND RELEASED.
Description of Event or Problem · 1
PATIENT ALLEGES THAT UNIT STOPPED WORKING AND HE HAD TO CALL THE EMERGENCY ROOM BECAUSE HE COULDN'T BREATHE. THE PATIENT WAS TREATED AT THE EMERGENCY ROOM AND RELEASE WITH FURTHER PROBLEMS. THERE WILL BE CONTINUED MONITORING OF COMPLAINTS FOR THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINIELITE COMPRESSOR NEBULIZER SYSTEM | COMPRESSOR NEBULIZER SYSTEM | CAF | RESPIRONICS NEW JERSEY, INC. | MINIELITE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention | ASTHMA MEDICATIONS FOR INHALATION |