FDA Adverse Event
Injury
Summary report: N
HT70 VENTILATOR
MDR report key: 3012523
·
Received March 15, 2013
Report
- Report Number
- 2023050-2013-00193
- Event Type
- Injury
- Date Received
- March 15, 2013
- Date of Event
- February 19, 2013
- Report Date
- February 20, 2013
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K090888
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH REQUESTED, ADD'L PATIENT INFO WAS NOT PROVIDED.
Description of Event or Problem · 1
DURING PATIENT USE, SUDDENLY AN ALARM OCCURRED AND VENTILATOR SHUTDOWN. AT THE TIME, THE HT70 STOPPED VENTILATING AND THE DISPLAY BECAME A BLACK SCREEN. A BURNING SMELL WAS NOTICED AT THAT TIME. THE PATIENT'S SPO2 DECREASED TO 88%. THE PATIENT WAS AMBU BAGGED AND SWITCHED TO ANOTHER VENTILATOR. NO PERMANENT INJURY WAS REPORTED IN THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110626 | HT70 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |