FDA Adverse Event
Malfunction
Summary report: N
NEBULIZER ADAPTOR
MDR report key: 1679305
·
Received May 3, 2010
Report
- Report Number
- 1417411-2010-00014
- Event Type
- Malfunction
- Date Received
- May 3, 2010
- Date of Event
- March 8, 2010
- Report Date
- April 7, 2010
- Manufacturer
- TELEFELX MEDICAL
- Product Code
- CAF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS REQUESTED BUT NOT RECEIVED AT TIME OF THIS REPORT. THE RESULTS OF THE DEVICE EVAL AND INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE DEVICE DID NOT WORK AT THE FLOW OF 6L/M. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEBULIZER ADAPTOR | NEBULIZER ADAPTOR | CAF | TELEFELX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |