FDA Adverse Event
Malfunction
Summary report: N
INSPIRATION ELITE COMPRESSOR NEBULIZER SYSTEM
MDR report key: 2096219
·
Received April 25, 2011
Report
- Report Number
- 2243193-2011-00002
- Event Type
- Malfunction
- Date Received
- April 25, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 25, 2011
- Manufacturer
- RESPIRONICS NEW JERSEY, INC.
- Product Code
- CAF
- PMA / PMN Number
- K042655
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NOISE AND START-UP FAILURES DO NOT LEAD TO THESE TYPES OF EVENTS AS THIS IS NOT A LIFE SUSTAINING DEVICE. ALTERNATE METHOD OF THERAPY SHOULD BE AVAILABLE (MDI). RESPIRONICS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS ISSUE.
Description of Event or Problem · 1
PT STATES HER NEBULIZER TOOK 20 MINS TO START UP. PT HAD TO CALL 911 BECAUSE HER ASTHMA GOT OUT OF CONTROL AND SHE WAS RUSHED TO HOSPITAL. SHE WENT TO (B)(6) HOSPITAL. SHE REMAINED IN HOSPITAL FOR 24 HRS AND WAS RELEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSPIRATION ELITE COMPRESSOR NEBULIZER SYSTEM | COMPRESSOR NEBULIZER | CAF | RESPIRONICS NEW JERSEY, INC. | HS456 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Hospitalization |