FDA Adverse Event
Malfunction
Summary report: N
HT70 VENTILATOR
MDR report key: 3810915
·
Received March 23, 2014
Report
- Report Number
- 2023050-2014-00124
- Event Type
- Malfunction
- Date Received
- March 23, 2014
- Date of Event
- January 1, 2014
- Report Date
- March 11, 2014
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K090888
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THE CUSTOMER RETURNED THE HT70 VENTILATOR FOR TWO DIFFERENT ISSUES. THE TOUCH SCREEN DID NOT WORK AFTER THE VENTILATOR FINISHED BOOTING UP. THE VENTILATOR WAS INVESTIGATED AND IT WAS DETERMINED THAT IT NEEDED THE TOP MEMBRANE AND AN OVERLAY REPLACED. THE MEMBRANE AND OVERLAY WERE REPLACED. (B)(4).
Description of Event or Problem · 1
COVIDIEN REC'D INFO STATING THAT AFTER THE VENTILATOR COMPLETED THE BOOT UP PROCESS, THE TOUCH SCREEN WAS UNRESPONSIVE. THE DEVICE WAS NOT IN USE ON A PATIENT WHEN THIS EVENT OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171117 | HT70 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT70M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |