VOYAGER TRANSPORT INCUBATOR
Received Dec 20, 2018 · Event occurred Dec 6, 2018
Report 8183858 · MDR key 8183858
Device
Generic name
Incubator, Neonatal Transport
Manufacturer
International Biomedical, Ltd.Catalog number
20035655
Product problems
- Failure to Deliver
- Gas/Air Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
NEONATAL TRANSPORT ISOLETTE/OXYGEN DELIVERY-BLENDER DEVICE FAILED DURING (AND PRIOR TO) NEONATAL INTENSIVE CARE UNIT (NICU) TRANSPORT. THIS CAUSED INABILITY TO BRINGING PATIENT BACK ON A LOW FIO2/LOW FLOW NASAL CANNULA, WHICH WAS CURRENT THERAPY ORDERED. HISTORY OF EVENT: BLENDER ALARM NOTED UPON INITIAL ASSESSMENT AROUND 10:00 AM-PRIOR TO LEAVING THE FACILITY ON TRANSPORT. THREE ADDITIONAL RTS EVALUATED THE BLENDER ALARM AND CAME TO THE CONCLUSION THAT BIOMED NEEDED TO BE INVOLVED. BIOMED WAS NOT IMMEDIATELY AVAILABLE, SO ENGINEERING CAME IMMEDIATELY AND THEN WAS ABLE TO INVOLVE BIOMED AFTER FURTHER ASSESSMENT. ONE OF THE AIR REGULATORS WAS FOUND TO HAVE A LARGE LEAK NO MATTER WHAT TROUBLESHOOTING WAS COMPLETED.