FDA Adverse Event
Malfunction
Summary report: N
HT70 VENTILATOR
MDR report key: 3032687
·
Received March 29, 2013
Report
- Report Number
- 2023050-2013-00250
- Event Type
- Malfunction
- Date Received
- March 29, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 11, 2013
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS
- Product Code
- CBK
- PMA / PMN Number
- K090888
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH REQUESTED, NO PATIENT INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
DURING PATIENT USE, SUDDENLY A "SWITCHED TO BACKUP BATTERY" OCCURRED WHEN THE AC CABLE WAS REMOVED. REPLACING THE POWER PAC BATTERY RESOLVED THE ISSUE. NO PATIENT INJURY WAS REPORTED IN THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 129802 | HT70 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |