FDA Adverse Event
Other
Summary report: N
MICROELITE NEBULIZER SYSTEM
MDR report key: 2111111
·
Received May 24, 2011
Report
- Report Number
- 2243193-2011-00004
- Event Type
- Other
- Date Received
- May 24, 2011
- Date of Event
- May 18, 2011
- Report Date
- May 24, 2011
- Manufacturer
- RESPIRONICS NEW JERSEY, INC.
- Product Code
- CAF
- PMA / PMN Number
- K063103
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FAX RECEIVED ON (B)(4) 2011 STATING DEVICE FAILURE AND ER VISIT BY PT AS A RESULT. SUBSEQUENT FOLLOWS-UPS ATTEMPTED TO GATHER MORE INFO, BUT NONE SUCCESSFUL. WILL WAIT AND SEE IF DEVICE IS RETURNED FOR EVAL.
Description of Event or Problem · 1
ON/OFF BUTTON DOES NOT WORK AND LIGHT IN ON/OFF BUTTON DOES NOT GO ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROELITE NEBULIZER SYSTEM | MICROELITE | CAF | RESPIRONICS NEW JERSEY, INC. | RDD491 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |