FDA Adverse Event
Other
Summary report: N
NEBULIZERS TO DELIVER AEROSOLS
MDR report key: 2114277
·
Received May 27, 2011
Report
- Report Number
- 1525712-2011-00211
- Event Type
- Other
- Date Received
- May 27, 2011
- Report Date
- May 27, 2011
- Manufacturer
- EMG
- Product Code
- JPW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEALER ALLEGES THE UNIT SMELLED LIKE BURNT PLASTIC. NO INJURY IS ALLEGED. THE NEBULIZER IS 2 YEARS OLD AND HISTORY HAS ALSO SHOWN THAT EVENTS WITH THIS DEVICE HAS BEEN A RESULT OF DROPPING DEVICE, MECHANICAL WEAR AND OR BLOCKING VENTS DURING USE. DEVICE IS THERMALLY PROTECTED. MDR FILED SOLELY ON COMPLAINT THAT THE DEALER SMELLED BURNT PLASTIC WHEN THEY TURNED ON THE NEBULIZER. MALFUNCTION NOT CONFIRMED. INVACARE IS ATTEMPTING TO OBTAIN PRODUCT FOR EVAL.
Description of Event or Problem · 1
THE DEALER WAS DEMONSTRATING THE UNIT TO A CUSTOMER AND THE UNIT ALLEGEDLY SMELLED LIKE BURNT PLASTIC. NO INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEBULIZERS TO DELIVER AEROSOLS | 868.5630 | JPW | EMG | IRC1740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |