FDA Adverse Event
Malfunction
Summary report: N
NEWPORT HT50 VENTILATOR
MDR report key: 741642
·
Received July 13, 2005
Report
- Report Number
- 2023050-2005-00017
- Event Type
- Malfunction
- Date Received
- July 13, 2005
- Date of Event
- June 17, 2005
- Report Date
- June 21, 2005
- Manufacturer
- FLIGHT MEDICAL LTD
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
H3: THE VENTILATOR WAS RECEIVED BY NEWPORT MEDICAL INSTRUMENTS INC ON 7/12/2005. IT WILL BE FORWARDED TO MANUFACTURER/FLIGHT MEDICAL LTD. FOR FURTHER INVESTIGATION. A FAILURE ANALYSIS REPORT AND ACTION TAKEN IN RESOLVING THIS ISSUE WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING TRANSPORTING TO HOSPITAL. THE VENTILATOR STARTED ALARMING AND SUDDENLY SHUT DOWN. THE VENTILATOR FAILED TO PROVIDE "LOW BATTERY" OR "EMPTY BATTERY" ALARMS PRIOR TO SHUT DOWN. PATIENT WAS VENTILATED BY AMBU BAG. THE VENTILATOR INDICATED "SYSTEM ERROR" AND CHANGED ITSELF TO STAND-MORE AFTER PLUGGED INTO AC-POWER SOURCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEWPORT HT50 VENTILATOR | VENTILATOR | CBK | FLIGHT MEDICAL LTD | HT50-H | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |