FDA Adverse Event
Other
Summary report: N
HOPE NEBULIZER
MDR report key: 3036034
·
Received February 15, 2013
Report
- Report Number
- 2938401-2013-00001
- Event Type
- Other
- Date Received
- February 15, 2013
- Date of Event
- January 14, 2013
- Report Date
- February 11, 2013
- Product Code
- CAF
- PMA / PMN Number
- K980407
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
LOT NUMBER D228515 IS CURRENTLY UNDER INVESTIGATION. B&B MEDICAL TECHNOLOGIES WILL F/U ONCE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
WHILE TRYING TO ADMINISTER TREATMENT WITH A CONTINUOUS MEDICATION/HELIOX NEBULIZER THE RESPIRATORY THERAPIST COULD NOT ACHIEVE THE 13-15 LITERS PER MINUTE FLOW NECESSARY TO NEBULIZE THE MEDICATION. IT SEEMED TO THE THERAPIST THAT THE SYSTEM WAS OCCLUDED. THE THERAPIST TRIED A DIFFERENT NEBULIZER WITH SAME EFFECT. THE THERAPIST THEN TRIED ANOTHER NEBULIZER FROM A DIFFERENT AND SUCCESSFULLY TREATED THE PT. ALL AFFECTED NEBULIZERS FROM THE SAME LOT NUMBER WAS REMOVED FROM INVENTORY FOR MFR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69535 | HOPE NEBULIZER | NEBULIZER | CAF | 11310 | D228515 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |