FDA Adverse Event
Malfunction
Summary report: N
HT70 PLUS VENTILATOR
MDR report key: 3082608
·
Received April 23, 2013
Report
- Report Number
- 2023050-2013-00333
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- March 22, 2013
- Report Date
- April 5, 2013
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K111146
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THOUGH REQUESTED, ADDITIONAL PT INFORMATION WAS NOT PROVIDED.
Description of Event or Problem · 1
REPORTEDLY, DURING SET-UP, WHEN THE VENTILATOR WAS GOING THROUGH THE START U PROCESS, THE TOUCH SCREEN TURNED BLUE AND WAS UNRESPONSIVE. THERE WERE NO ADVERSE PT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173493 | HT70 PLUS VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT70PM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |