FDA Adverse Event
Injury
Summary report: N
HT70 PLUS VENTILATOR
MDR report key: 6091577
·
Received November 9, 2016
Report
- Report Number
- 2023050-2016-00684
- Event Type
- Injury
- Date Received
- November 9, 2016
- Report Date
- October 14, 2016
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC
- Product Code
- CBK
- PMA / PMN Number
- K111146
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AFTER CHECKING THE VENTILATION USING AN ARTIFICIAL LUNG THE SAME CONDITION OCCURRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PATIENT USE THE HT70 VENTILATOR HAD HIGH AIRWAY PRESSURE, OCCLUSION AND BREAKS IN THE VENTILATION OF THE PATIENT. THERE WAS NO PATIENT HARM/INJURY REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 741691 | HT70 PLUS VENTILATOR | CONTINUOUS VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |