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 ROTATING IV POLE; STAND, INFUSION
  • 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 ROTATING IV POLE; STAND, INFUSION Back to Search Results
Catalog Number 6600-0851-800
Device Problems Break (1069); Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2021
Event Type  malfunction  
Event Description
Nurse reported she was putting an oxygen flow monitor on the wall behind an infant warmer in the well-baby nursery.She moved the ohmeda medical rotating iv pole out of the way (which is attached to the infant warmer) and it all snapped off and fell.Nurse checked the screws that secure the rotating iv pole to the warmer and the metal holding it together had broken.The weight limit for the pole is 9 kg.The two infusion devices on the rotating iv pole had a combined weight of 4.21 kg which is less than the weight limit.If there had been a baby in that warmer it could have severely injured the baby.Clinical engineering completed an investigation of this event and found that the internal sleeve in which the bolt that secures clamping part to the pole was sheared off.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ROTATING IV POLE
Type of Device
STAND, INFUSION
Manufacturer (Section D)
OHMEDA MEDICAL
3030 ohmeda drive
madison WI 53718
MDR Report Key11731527
MDR Text Key247556484
Report Number11731527
Device Sequence Number1
Product Code FOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6600-0851-800
Device Lot NumberLAU14256889
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/20/2021
Event Location Hospital
Date Report to Manufacturer04/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-