FDA Adverse Event
Summary report: N
HT50 VENTILATOR
MDR report key: 2061190
·
Received April 6, 2011
Report
- Report Number
- 2023050-2011-00011
- Date Received
- April 6, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 10, 2011
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K082724
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
REPORTEDLY, WHILE RUNNING ON A BATTERY POWER, THE VENTILATOR SHUTDOWN WITH BATTERY SYSTEM FAILURE. THE VENTILATOR GAVE A LOW BATTERY ALARM ONE MINUTE PRIOR TO SHUTDOWN. PLEASE NOTE THAT THERE WAS NO PT INVOLVEMENT. HOWEVER, IF IT WERE TO RECUR IT WOULD NOT ALLOW ENOUGH TIME FOR A USER TO REACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HT50 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT50-H1B | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |