FDA Adverse Event
Other
Summary report: N
PALL HEAT & MOISTURE EXCHANGER FILTER
MDR report key: 322517
·
Received March 23, 2001
Report
- Report Number
- 2647898-2001-00005
- Event Type
- Other
- Date Received
- March 23, 2001
- Report Date
- March 2, 2001
- Manufacturer
- PALL BIOMEDICAL INC.
- Product Code
- BYD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT IN ICU WAS BEING VENTILATED WITH THE DEVICE IN PLACE AND THE VENTILATOR ALARMED. THE RESPIRATORY THERAPIST NOTICED THE PT WAS CYANOTIC AND THE DEVICE WAS REMOVED. NO PT SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12904 | PALL HEAT & MOISTURE EXCHANGER FILTER | HEAT & MOISTURE EXCHANGER FILTER | BYD | PALL BIOMEDICAL INC. | HME15-22 | 034304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |