FDA Adverse Event
Injury
Summary report: N
HT70 VENTILATOR
MDR report key: 2792200
·
Received October 11, 2012
Report
- Report Number
- 2023050-2012-00215
- Event Type
- Injury
- Date Received
- October 11, 2012
- Date of Event
- September 14, 2012
- Report Date
- September 23, 2012
- Manufacturer
- NEWPORT MEDICAL INSTRUMENT
- 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, PT INFORMATION WAS NOT PROVIDED.
Description of Event or Problem · 1
REPORTEDLY, DURING PT USE, THERE WAS A "SWITCHED TO BACKUP BATTERY" ALARM WHEN THE VENTILATOR WAS ON AC POWER. THE PT WAS MANUALLY VENTILATED BEFORE BEING TRANSFERRED TO ANOTHER VENTILATOR. 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 INSTRUMENT | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |