FDA Adverse Event
Injury
Summary report: N
HT70 PLUS VENTILATOR
MDR report key: 6472514
·
Received April 7, 2017
Report
- Report Number
- 2023050-2017-05139
- Event Type
- Injury
- Date Received
- April 7, 2017
- Date of Event
- September 4, 2015
- Report Date
- September 29, 2015
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC
- Product Code
- CBK
- PMA / PMN Number
- K111146
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO PLACING A PATIENT ON THE HT70 VENTILATOR, IT WOULD NOT START UP BY PRESSING THE SWITCH. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT. INFORMATION REGARDING IF THE THERE WAS A DELAY IN THE PATIENTS THERAPY AND IF THE PATIENT WAS MANUALLY VENTILATED / AMBU BAGGED WAS REQUESTED HOWEVER COULD NOT BE OBTAINED FROM THE CUSTOMER. THE CUSTOMER COULD NOT DUPLICATE THE REPORTED ISSUE.
Description of Event or Problem · 1
REFERENCE REGULATORY REPORT #2023050-2017-05151 PREVIOUSLY REPORTED FOR THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255199 | HT70 PLUS VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | NEWPORT MEDICAL INSTRUMENTS, INC | HT70 PLUS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |