FDA Adverse Event
Other
Summary report: N
ULTIPOR 100
MDR report key: 807204
·
Received January 19, 2007
Report
- Report Number
- MW1041679
- Event Type
- Other
- Date Received
- January 19, 2007
- Date of Event
- January 9, 2007
- Report Date
- January 19, 2007
- Manufacturer
- PALL LIFE SCIENCES
- Product Code
- CAH
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT VENT HIGH PRESSURE ALARM SOUNDED. RESPIRATORY AND NURSING RESPONDED TO FIND PT WITH DECREASE IN LOC AND LABORED BREATHING. SUCTIONED AND BAGGED THE PT BUT MET WITH RESISTANCE. RESPIRATORY REMOVED THE ULTIPOR 100 FILTER AND WAS ABLE TO BAG THE PT WITHOUT DIFFICULTY. PT RETURNED TO BASELINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTIPOR 100 | VENTILATOR FILTER | CAH | PALL LIFE SCIENCES | ULTIPOR 100 | 524807 525102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |