FDA Adverse Event
Other
Summary report: N
BACTERIAL/VIRAL FILTER (PART OF BREATHING CIRCUIT)
MDR report key: 80415
·
Received March 27, 1997
Report
- Report Number
- 2242551-1997-00015
- Event Type
- Other
- Date Received
- March 27, 1997
- Date of Event
- February 25, 1997
- Report Date
- February 25, 1997
- Manufacturer
- VITAL SIGNS, INC.
- Product Code
- CAH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
(AS WAS REPORTED TO CO'S SALES REP BY THE USER FACILITY...) USER DISCOVERED FILTER HOUSING WAS CRACKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BACTERIAL/VIRAL FILTER (PART OF BREATHING CIRCUIT) | BACTERIAL/VIRAL FILTER | CAH | VITAL SIGNS, INC. | NA | 008X & 021Y |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |