FDA Adverse Event
Injury
Summary report: N
HT70 VENTILATOR
MDR report key: 2860420
·
Received December 4, 2012
Report
- Report Number
- 2023050-2012-00331
- Event Type
- Injury
- Date Received
- December 4, 2012
- Date of Event
- November 15, 2012
- Report Date
- November 18, 2012
- 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
THOUGH REQUESTED, ADD'L PT INFO WAS NOT PROVIDED.
Description of Event or Problem · 1
REPORTEDLY, DURING PT USE, A "MOTOR FAULT ALARM" OCCURRED FOLLOWED BY A DEVICE ALERT. THE VENTILATOR STOPPED VENTILATING SOON AFTER. THE PT WAS MANUALLY VENTILATED AND TRANSFERRED TO ANOTHER VENTILATOR. THE NEXT DAY, WHEN THE VENTILATOR WAS ALLOWED TO VENTILATE, A "PINT FAILURE" OCCURRED AND A DEVICE ALERT OCCURRED AGAIN. THERE WERE NO ADVERSE PT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HT70 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |