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: SKYTRON LLC ELITE; TABLE, OPERATING-ROOM, AC-POWERED
  • 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
 

SKYTRON LLC ELITE; TABLE, OPERATING-ROOM, AC-POWERED Back to Search Results
Model Number 6302
Device Problems Unintended Ejection (1234); Unintended System Motion (1430)
Patient Problem Insufficient Information (4580)
Event Date 03/16/2021
Event Type  malfunction  
Event Description
I was called to or 7 to look at or table, which per certified registered nurse anesthetist (crna) was not functioning correctly.The or table appeared to have a hydraulic leak that may have been causing the table to malfunction.Head of bed was very slowly dropping, which is how/when anesthesia noticed a problem.Table info: mizuho, skytron elite 6302.The decision was made by the surgical team, surgeon and anesthesia to change beds before prep and drape (patient had already been intubated).The bed hydraulic leak was not noticed until the patient had been intubated.The weight of the patient may have made the leak more pronounced to where staff could see the leak.Table was immediately taken out of use and labeled do not use.Manufacturer representative was contacted to fix the bed asap.He confirmed he will be here next day morning before cases start.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ELITE
Type of Device
TABLE, OPERATING-ROOM, AC-POWERED
Manufacturer (Section D)
SKYTRON LLC
5085 corporate exchange blvd se
grand rapids MI 49512
MDR Report Key11626857
MDR Text Key244194372
Report Number11626857
Device Sequence Number1
Product Code FQO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6302
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/04/2021
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer04/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age13140 DA
-
-