FDA Adverse Event
Malfunction
Summary report: N
E500
MDR report key: 2926419
·
Received January 18, 2013
Report
- Report Number
- 2926419
- Event Type
- Malfunction
- Date Received
- January 18, 2013
- Date of Event
- January 12, 2013
- Report Date
- January 18, 2013
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
RESPIRATORY TECHNICIAN REPORTS VENTILATOR SHUT OFF AND DEVICE ALERT APPEARED ON SCREEN. VENTILATOR WAS POWERED BACK ON AND WAS OPERATIONAL. VENTILATOR WAS REPLACED WITH ANOTHER ONE. BIOMED CHECKED EVENT HISTORY LOG ON VENTILATOR; SHOWED EVENT "POWER FAILURE", EVENT AT "DEVICE FAIL" AND AT "POWER BACK ON" WITHIN SEVERAL MINUTES. DID NOT SEE ANY LOG OF UNIT OPERATING ON BATTERY BACK-UP. CONTACTED NEWPORT MEDICAL INSTRUMENTS AND FILED THEIR COMPLAINT FORM ON-LINE.======================MANUFACTURER RESPONSE FOR VENTILATOR, E-500 (PER SITE REPORTER).======================AWAITING RESPONSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27948 | E500 | VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC | E500 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |