FDA Adverse Event
Injury
Summary report: N
HT70 VENTILATOR
MDR report key: 6119095
·
Received November 21, 2016
Report
- Report Number
- 2023050-2016-00710
- Event Type
- Injury
- Date Received
- November 21, 2016
- Date of Event
- October 24, 2016
- Report Date
- October 27, 2016
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC
- Product Code
- CBK
- PMA / PMN Number
- K090888
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE EVALUATION AND REPAIR WILL BE COMPLETED BY A NON-COVIDIEN SERVICE PROVIDER. COVIDIEN WAS NOT AUTHORIZED TO EVALUATE THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT, DURING USE ON A PATIENT, AN HT70 VENTILATOR WENT INTO A VENTILATOR INOPERABLE CONDITION AND SHUT DOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 768830 | HT70 VENTILATOR | CONTINUOUS VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |