FDA Adverse Event Injury Summary report: N

OXYLOG 3000

MDR report key: 3811828 · Received May 9, 2014

Report

Report Number
MW5036080
Event Type
Injury
Date Received
May 9, 2014
Date of Event
May 7, 2014
Report Date
May 8, 2014
Manufacturer
DRAGER
Product Code
CBK
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OK, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

A (B)(6) IN RESPIRATORY FAILURE. INTUBATED IN A (B)(6) HOSPITAL. NEEDED TRANSPORT TO HIGHER LEVEL CARE. AMBULANCE TEAM FROM (B)(6) EMS CAME WITH DRAGER OXYLOG 300 VENTILATOR. VENTILATOR FAILED TWICE ON INFANT, ONCE IN THE AMBULANCE BEFORE LEAVING THE HOSPITAL. VENTILATOR HAD DIFFICULTY VENTILATING BABY AND KEEPING SATURATIONS UP. AFTER ABOUT 15-20 MIN VENTILATOR STARTED A "FLUTTERING" AIR FLOW PATTERN WHILE STILL ON THE CONTROLLED VENTILATION MODE. SATURATIONS DROPPED INTO THE 50'S. BABY WAS BAG-ETT VENTILATED AND RETURNED TO EMERGENCY ROOM TRAUMA BAY, AND PLACED ON OHMEDA VENTILATOR PRESSURE SUPPORT WITH PEEP. AFTER STABILIZED, DRAGER OXYLOG 3000 WAS AGAIN PLACED ON BABY ON VENT. WITH SIMILAR SETTINGS, CV INSTEAD OF PS. GOOD CHEST RISE WITH EQUAL BREATH SOUNDS. AGAIN SAT'S DECREASED WITHIN A FEW MINUTES TO 97%. THEN AT ABOUT 15 MIN, VENTILATOR WENT INTO A "FLUTTERY" RAPID SHALLOW INSP/EXP FLOW PATTERN WHILE ON SAME SETTINGS. THE PARAMEDICS SAID THEY HAD NEVER SEEN THAT HAPPEN WITH THEIR VENTILATOR. DEVICE WAS BROUGHT OVER BY (B)(6) EMS SERVICES AMBULANCE AND THEIR CREW. I CALLED TODAY TO TRY TO GET MAKE, MODEL INFO, BUT WAS TOLD BY SUPERVISOR, (B)(6), THAT THEY WOULD NOT RELEASE THAT INFORMATION, THAT I WOULD HAVE TO CONTACT THEIR LEGAL AND/OR BIOMED DEPARTMENTS TO TRY TO GET THAT INFORMATION. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
281299 OXYLOG 3000 VENTILATOR CBK DRAGER

Patients

Seq Age Sex Outcome Treatment
1 3 MO Hospitalization| L| R