FDA Adverse Event
Injury
Summary report: N
HT70 VENTILATOR
MDR report key: 6071474
·
Received November 1, 2016
Report
- Report Number
- 2023050-2016-00664
- Event Type
- Injury
- Date Received
- November 1, 2016
- Date of Event
- October 2, 2016
- Report Date
- October 5, 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
COVIDIEN REFERENCE NUMBER: (B)(4). MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PATIENT USE THE VENTILATOR GENERATED A BACKUP BATTERY FAILURE ALARM. THE DEVICE CONTINUED VENTILATING/CYCLING. THE PATIENT WAS TRANSFERRED TO A DIFFERENT VENTILATOR. THERE WAS NO PATIENT HARM/INJURY REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 721727 | HT70 VENTILATOR | CONTINUOUS VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |