inforMED
MalfunctionFPL

AIRBORNE 750I INFANT

Received Mar 6, 2015 · Event occurred Dec 7, 2014

Report 4591765 · MDR key 4591765

Device

Generic name

Incubator, Neonatal Transport

Model number

750I

Catalog number

*

Lot number

*

Product problems

  • Loose or Intermittent Connection
  • Device Slipped

Patient

0 *

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

A NEWBORN WAS IN TRANSIT TO THE NICU IN THE DEVICE. AS THE NURSE ENTERED THE ROOM WITH THE DEVICE, THE TOP PORTION OF THE DEVICE STARTED TO SLIDE OFF THE BASE. THE NURSE IMMEDIATELY STOPPED AND REMOVED THE NEWBORN FROM THE DEVICE. THE NEWBORN WAS TRANSPORTED IN ARMS THE REST OF THE WAY INTO THE ROOM AND PLACED IN THE WARMER.THE DEVICE WAS REMOVED FROM SERVICE AND SENT TO BIOMED FOR EXAMINATION. BIOMED DETERMINED THAT THE 4 BOLTS THAT HOLD THE TOP PORTION OF THE DEVICE HAD COME LOOSE. THE LOOSE BOLTS WERE REPLACED. THE BOLTS ARE LOCATED NEAR SHOCK ABSORBERS, WHICH MAY HAVE CONTRIBUTED TO THE LOOSE BOLTS. OUR BIOMED TEAM DETERMINED THAT THE BOLTS SHOULD BE ADDED TO THE 6 MONTH PREVENTATIVE MAINTENANCE SCHEDULE FOR THIS DEVICE.