Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERNATIONAL BIOMEDICAL AIRBORNE 750I; INCUBATOR, NEONATAL TRANSPORT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTERNATIONAL BIOMEDICAL AIRBORNE 750I; INCUBATOR, NEONATAL TRANSPORT Back to Search Results
Model Number A750I
Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 05/27/2021
Event Type  malfunction  
Event Description
During set up and preparation of the in-house transport isolette, the nurse noticed a strong electrical smell from the isolette chamber.She immediately unplugged the unit from ac power and removed the isolette from the care area.Biomedical engineering retrieved the unit and opened device for inspection.The bme found the high current bridge rectifier burnt along with the bridge lead going to the power terminal block.The bme also noted swelling of the 12v 28ah internal battery.Review of the service history on this isolette and other of the same model noted the same component failure in two previous repairs on two separate devices.Parts ordered and isolette scheduled for repair.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AIRBORNE 750I
Type of Device
INCUBATOR, NEONATAL TRANSPORT
Manufacturer (Section D)
INTERNATIONAL BIOMEDICAL
8206 cross park drive
austin TX 78754
MDR Report Key11945903
MDR Text Key254530652
Report Number11945903
Device Sequence Number1
Product Code FPL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA750I
Device Catalogue Number731-0160
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/03/2021
Device Age10 YR
Event Location Hospital
Date Report to Manufacturer06/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-