FDA Adverse Event
Malfunction
Summary report: N
OPTIONHOME: COMPRESSOR DISPOSABLE SIDESTREAM
MDR report key: 2269058
·
Received September 9, 2011
Report
- Report Number
- 2243193-2011-00006
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- June 7, 2011
- Report Date
- September 8, 2011
- Manufacturer
- RESPIRONICS NEW JERSEY, INC.
- Product Code
- CAF
- PMA / PMN Number
- K072494
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SERIAL NUMBER NOT PROVIDED BY PERSON LOGGING COMPLAINT. DEVICE WAS UNAVAILABLE FOR EVAL AS PT DID NOT WANT TO RETURN DEVICE. PT DID NOT SEEK MEDICAL INTERVENTION. FILING ONLY FOR ALLEGATION THAT DEVICE MADE HER FEEL SICK. NO PERMANENT INJURY OR OTHER ADVERSE EVENT. ALL MATERIALS USED IN AIR PATH HAVE BEEN TESTED TO (B)(4).
Description of Event or Problem · 1
CUSTOMER ALLEGES THAT WHEN SHE USED THE DEVICE IT GAVE OFF THIS HORRIBLE SMELL AND MADE HER FEEL LIKE HER LUNGS WERE "BURNING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTIONHOME: COMPRESSOR DISPOSABLE SIDESTREAM | OPTIONHOME | CAF | RESPIRONICS NEW JERSEY, INC. | 1059751 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |