FDA Adverse Event Injury Summary report: N

NEWPORT HT50 VENTILATOR

MDR report key: 2100921 · Received May 18, 2011

Report

Report Number
MW5020668
Event Type
Injury
Date Received
May 18, 2011
Date of Event
May 6, 2011
Report Date
May 18, 2011
Manufacturer
NEWPORT NMI INC
Product Code
CBK
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
RI, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

VENTILATOR (NEWPORT HT50) WAS OPERATING ON RESIDENT WHILE USING INTERNAL BATTERY. RESIDENT WAS BEING TRANSFERRED IN THE HALLWAY, VENTILATOR ALARMED ONE LONG ALARM TONE THEN STOPPED OPERATING. RESIDENT WAS WITH STAFF MEMBER THAT IMMEDIATELY BEGAN MANUALLY VENTILATING THE RESIDENT AND RESPIRATORY THERAPIST WAS CALLED. THERAPIST NOTED VENTILATOR NOT TO BE OPERATING AND ATTEMPTED TO TURN THE VENTILATOR ON AND VENTILATOR BEGAN OPERATING AGAIN AND VOLUMES AND PRESSURES WERE NOTED IN THE MONITORING SCREEN OF VENTILATOR. VENTILATOR OPERATING FOR 2-3 MINS AND THEN SHUT DOWN AGAIN, NOTING AUDIBLE ALARM. VENTILATOR WAS REMOVED FROM SERVICE IMMEDIATELY AND RESIDENT WAS PLACED ON ANOTHER VENTILATOR. VENTILATOR WAS NOTED TO HAVE A DEVICE ALERT LIGHT ON AND "SYSTEM ERROR" ON FRONT PANEL AND MONITORING WINDOW.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NEWPORT HT50 VENTILATOR NEWPORT HT50 VENTILATOR CBK NEWPORT NMI INC HT50 NA

Patients

Seq Age Sex Outcome Treatment
1 32 YR Disability