VOYAGER TRANSPORT
Received Aug 10, 2021 · Event occurred Aug 3, 2021
Report 12301117 · MDR key 12301117
Device
Generic name
Incubator, Neonatal Transport
Manufacturer
International Biomedical, Ltd.Model number
PULSEOX VOYAGER 731-1615Product problems
- Break
- Corroded
- Disconnection
- Leak/Splash
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
DURING BIOMEDICAL SERVICE ON THE TRANSPORT ISOLETTE, THE BIOMED ENGINEER FOUND THE ISOLETTE INTERNAL BATTERY CORRODED AND LEAKING ELECTROLYTE THROUGHOUT THE BATTERY BAY. BME FOUND DAMAGED WIRING AND NEGATIVE BATTERY POST COMPLETE CORRODED AND DISCONNECTED. THERE IS EXTENSIVE DAMAGE TO INTERIOR OF BATTERY BAY WHICH WILL REQUIRE RE-WORK AND SURFACE PROTECTION. THERE WAS ALSO EXTENSIVE CORROSION DAMAGE ON ALL GROUNDING POSTS ON THE INTERIOR BATTERY BAY. DEVICE PLACED OUT OF SERVICE TO EXTENSIVE REPAIR WORK. ESTIMATED BATTERY AGE OF 24 MONTHS 12VDC 28AH RATING. MANUFACTURER RESPONSE FOR CRITICAL CARE TRANSPORT ISOLETTE, VOYAGER TRANSPORT (PER SITE REPORTER). AWAITING MANUFACTURER RESPONSE AND ON-SITE VISIT TO DETERMINE ROOT CAUSE OF FAILURE.