FDA Adverse Event
Malfunction
Summary report: N
AQUESURE FILTER HUMIDIFIER
MDR report key: 4563604
·
Received February 27, 2015
Report
- Report Number
- 3003213883-2015-00001
- Event Type
- Malfunction
- Date Received
- February 27, 2015
- Date of Event
- January 28, 2015
- Report Date
- February 25, 2015
- Manufacturer
- BOMIMED INC.
- Product Code
- CAH
- PMA / PMN Number
- K851070
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). WAITING ON ADDITIONAL CIRCUMSTANCE AND ENVIRONMENTAL FACTORS AT THE TIME OF THE INCIDENT FROM THE HOSPITAL.
Description of Event or Problem · 1
AFTER CONTINUED USE ON A VENTILATED PATIENT, THE PATIENT WENT INTO RESPIRATORY DISTRESS. IT WAS DISCOVERED THE FILTER WAS PLUGGED, THEREFORE IT WAS CHANGED OUT AND NO APPARENT PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 140246 | AQUESURE FILTER HUMIDIFIER | BACT/VIRAL FILTER W/HUMIDIFICATION | CAH | BOMIMED INC. | OL-040750-00 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |