FDA Adverse Event
Other
Summary report: N
HT50 VENTILATOR
MDR report key: 1894155
·
Received November 4, 2010
Report
- Report Number
- 2023050-2010-00051
- Event Type
- Other
- Date Received
- November 4, 2010
- Date of Event
- October 10, 2010
- Report Date
- October 10, 2010
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K082724
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN AND THE DEVICE ALARMED AS EXPECTED. THE PT WAS AT A FAMILY EVENT OUTSIDE THE HOSPITAL. THE PT WAS MANUALLY VENTILATED. THE RESPIRATORY THERAPIST ON CALL BROUGHT A SECOND VENTILATOR TO THE SITE AND TRANSFERRED THE PT TO THE SECOND VENTILATOR. NO SERIOUS PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HT50 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |