FDA Adverse Event
Other
Summary report: N
INSPIRATION ELITE
MDR report key: 2693585
·
Received August 8, 2012
Report
- Report Number
- 2243193-2012-00005
- Event Type
- Other
- Date Received
- August 8, 2012
- Date of Event
- July 16, 2012
- Report Date
- August 2, 2012
- Manufacturer
- RESPIRONICS NEW JERSEY INC
- Product Code
- CAF
- PMA / PMN Number
- K042655
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DISTRIBUTOR (B)(4) WAS CONTACTED IN AN ATTEMPT TO GET THIS DEVICE BACK WITH NO SUCCESS. WILL MONITOR COMPLAINT TRENDS FOR THIS FAILURE TYPE.
Description of Event or Problem · 1
PT STATES THAT DEVICE IS TAKING OVER AN HOUR TO DELIVER THE DOSE AND THAT MEDICATION IS NOT COMING THE WHOLE WAY THROUGH. SHE STATES THAT SINCE SHE WAS NOT ABLE TO TAKE HER MEDICATION, SHE BECAME VERY DISTRESSED, WHICH IN TURN MAKES HER ASTHMA WORSE. SHE HAD TO CONTACT HER PHYSICIAN AND RECEIVED ANOTHER COMPRESSOR NEBULIZER SYSTEM. NO SERIOUS INJURY OR PERMANENT HARM WAS CONVEYED BY THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSPIRATION ELITE | COMPRESSOR NEBULIZER SYSTEM | CAF | RESPIRONICS NEW JERSEY INC | HS456 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |