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: GYRUS ACMI, INC MULTIDEBRIDER POWER CONSOLE
  • 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
 

GYRUS ACMI, INC MULTIDEBRIDER POWER CONSOLE Back to Search Results
Model Number MDCONS100
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The customer have not returned the subject device.The definitive root cause could not be confirmed as it was later reported that the device was found to be functional.Olympus will continue to monitor complaints for this device.
 
Event Description
It was reported that the device console not functioning as intended, foot pedal connection issue.The console would not read the foot pedal.There was no patient involvement on this event.No user injury reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MULTIDEBRIDER POWER CONSOLE
Type of Device
MULTIDEBRIDER POWER CONSOLE
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough MA 01772
Manufacturer Contact
kenneth pittman
2925 appling rd
bartlett, TN 38133
9013785969
MDR Report Key11345198
MDR Text Key244920715
Report Number1037007-2021-00021
Device Sequence Number1
Product Code GEI
UDI-Device Identifier00821925027770
UDI-Public00821925027770
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123429
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMDCONS100
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/27/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/05/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-