FDA Adverse Event
Injury
Summary report: N
HT50 VENTILATOR
MDR report key: 6472034
·
Received April 7, 2017
Report
- Report Number
- 2023050-2017-05138
- Event Type
- Injury
- Date Received
- April 7, 2017
- Date of Event
- December 2, 2014
- Report Date
- December 4, 2014
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC
- Product Code
- CBK
- PMA / PMN Number
- K082724
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING USE, THE HT50 VENTILATOR INSPIRATION: EXPIRATION (I:E) VALUE BECAME 1:1.0. A TECHNICIAN PRESSED THE I:E BUTTON THEN THE VALUE BECAME 1:3.0. THE VENTILATOR DID NOT STOP CYCLING. HOWEVER, THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED ISSUE. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE.
Description of Event or Problem · 1
THIS MEDWATCH REPORT WAS INADVERTENTLY SUBMITTED. REGULATORY REPORT #2023050-2017-05150 WAS SUBMITTED TO ADDRESS THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255649 | HT50 VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | NEWPORT MEDICAL INSTRUMENTS, INC | HT50 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |