FDA Adverse Event
Malfunction
Summary report: N
HT70 PLUS VENTILATOR
MDR report key: 3962622
·
Received June 18, 2014
Report
- Report Number
- 2023050-2014-00248
- Event Type
- Malfunction
- Date Received
- June 18, 2014
- Date of Event
- May 22, 2014
- Report Date
- May 23, 2014
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K111146
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE UNIT, AND VERIFIED THE REPORTED MALFUNCTION. THE CSE REPLACED THE COIN BATTERY, WHICH RESOLVED THE REPORTED ISSUE. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, AN HT70 PLUS VENTILATOR TOUCH SCREEN WAS UNRESPONSIVE AND DISPLAYING AN ERROR CODE "COIN BATTERY NEEDS TO BE REPLACED", WHILE THE CUSTOMER WAS TRYING TO POWER ON THE UNIT. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 356899 | HT70 PLUS VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |