FDA Adverse Event
Malfunction
Summary report: N
HT70
MDR report key: 6187712
·
Received December 19, 2016
Report
- Report Number
- 2023050-2016-00758
- Event Type
- Malfunction
- Date Received
- December 19, 2016
- Report Date
- December 20, 2017
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC
- Product Code
- CBK
- PMA / PMN Number
- K090888
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE SE REPLACED THE DISPLAY AND THE PUMP, AS REPORTEDLY IT HAD EXCESSIVE AMOUNT OF DEBRIS INSIDE. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.
Additional Manufacturer Narrative · 1
THE DEVICE WAS REPAIRED AND THE REPORTED ISSUE WAS ISOLATED TO A MECHANICAL PROBLEM. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE THE HT70 VENTILATOR DISPLAY WENT BLANK. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 835809 | HT70 | CONTINUOUS VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |