FDA Adverse Event
Injury
Summary report: N
HT70
MDR report key: 3001619
·
Received March 11, 2013
Report
- Report Number
- 2023050-2013-00170
- Event Type
- Injury
- Date Received
- March 11, 2013
- Date of Event
- February 15, 2013
- Report Date
- February 19, 2013
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K090888
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THOUGH REQUESTED, PATIENT INFORMATION WAS NOT PROVIDED.
Description of Event or Problem · 1
DURING PATIENT USE, SUDDENLY AT "SWITCHED TO BACKUP BATTERY" ALARM OCCURRED WHEN THE AC CABLE WAS REMOVED. THE PATIENT WAS AMBU BAGGED AND SWITCHED OT ANOTHER VENTILATOR. REPLACING THE POWER PAC BATTERY RESOLVED THE ISSUE. NO PERMANENT PATIENT INJURY WAS REPORTED IN THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101340 | HT70 | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |