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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERNATIONAL BIOMEDICAL, LTD. AIRBORNE 750I INFANT; INCUBATOR, NEONATAL TRANSPORT
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INTERNATIONAL BIOMEDICAL, LTD. AIRBORNE 750I INFANT; INCUBATOR, NEONATAL TRANSPORT Back to Search Results
Model Number 750I
Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2014
Event Type  malfunction  
Event Description
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.
 
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Brand Name
AIRBORNE 750I INFANT
Type of Device
INCUBATOR, NEONATAL TRANSPORT
Manufacturer (Section D)
INTERNATIONAL BIOMEDICAL, LTD.
8508 cross park drive
austin TX 78754
MDR Report Key4591765
MDR Text Key20364282
Report Number4591765
Device Sequence Number1
Product Code FPL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 03/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model Number750I
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/06/2015
Event Location Hospital
Date Report to Manufacturer03/11/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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