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: 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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fall (1848)
Event Date 10/23/2018
Event Type  malfunction  
Event Description
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GIRAFFE WARMER
Type of Device
WARMER, INFANT RADIANT
Manufacturer (Section D)
OHMEDA MEDICAL
8880 gorman rd
laurel MD 20723
MDR Report Key8008594
MDR Text Key125149670
Report Number8008594
Device Sequence Number1
Product Code FMT
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 10/24/2018,10/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2018
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/24/2018
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer10/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age35 DA
-
-