FDA Adverse Event
Other
Summary report: N
WARMER BLOOD/SOLUTION FAST FLOW
MDR report key: 922280
·
Received October 2, 2007
Report
- Report Number
- 1221261-2007-00046
- Event Type
- Other
- Date Received
- October 2, 2007
- Date of Event
- August 8, 2007
- Report Date
- September 4, 2007
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- BSB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION - OTHER: WE HAVE RECEIVED THE SAMPLE INVOLVED WITH THIS REPORT. IT HAS BEEN FORWARDED TO MEDO (THE MANUFACTURER) FOR INVESTIGATION. UPON RECEIPT OF THE INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
USER ALLEGES THAT THE COMPRESSOR WAS NOT WORKING DURING A PROCEDURE. EVENT OCCURRED IN ANOTHER COUNTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WARMER BLOOD/SOLUTION FAST FLOW | 81BSB FLUID WARMER IRRIGATING | BSB | SMITHS MEDICAL ASD, INC. | H-1200 | 20060151 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |