FDA Adverse Event
Injury
Summary report: N
HT70 VENTILATOR
MDR report key: 3012547
·
Received March 15, 2013
Report
- Report Number
- 2023050-2013-00180
- Event Type
- Injury
- Date Received
- March 15, 2013
- Date of Event
- February 2, 2013
- Report Date
- February 19, 2013
- 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
ALTHOUGH REQUESTED, ADDITIONAL PT INFO WAS NOT PROVIDED.
Description of Event or Problem · 1
DURING PT USE, IT WAS FOUND THAT THE AUTO LOCK WAS NON-FUNCTIONAL. ALSO THE ALARM SILENCE LED DID BLINK ON AND OFF. THE PT 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 |
|---|---|---|---|---|---|---|---|
| 110628 | HT70 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENT | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |