• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OHMEDA MEDICAL GIRAFFE WARMER WARMER, INFANT RADIANT

  • 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
 

OHMEDA MEDICAL GIRAFFE WARMER WARMER, INFANT RADIANT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Skull Fracture (2077)
Event Date 10/23/2018
Event Type  Injury  
Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed. Maude data base mdr report source # (b)(4). Device evaluation anticipated, but not yet begun.
 
Event Description
Anonymous report number #(b)(4) from maude database states, "rn responded to monitor alarming in pt room. Rn found patient lying on floor out of giraffe bed, crying, with bottom side rail down. Bed was found in the reverse trendelenburg position which is appropriate for pt. Rn hit emergency button and yelled for help. Second rn to bedside- picked pt up from first rn arms and placed pt back in bed. Pt was moving all four extremities appropriately and crying spontaneously. Picu team called apn and md to bedside to assess pt. Pt placed back on cardiac monitor and sipap machine after assessment. Neuro check done per md to assess pt status. Pt with appropriate neuro assessment. Q2 hour neuro checks ordered per picu team. Giraffe bed removed from room and new junior crib placed in room. " additional information was received that the patient suffered a skull fracture from the fall. There was no reported additional medical intervention or extended hospital stay as a result of the fall.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGIRAFFE WARMER
Type of DeviceWARMER, INFANT RADIANT
Manufacturer (Section D)
OHMEDA MEDICAL
8880 gorman rd
laurel, MD 20723
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key8128410
MDR Text Key129170727
Report Number1121732-2018-00011
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101788
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Biomedical Engineer
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberFMI32067

Patient Treatment Data
Date Received: 12/04/2018 Patient Sequence Number: 1
-
-