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

MAUDE Adverse Event Report: PENLON, INC. PENLON

  • 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
 

PENLON, INC. PENLON Back to Search Results
Model Number PRIMA 460
Device Problem Failure to Power Up (1476)
Patient Problem No Information (3190)
Event Date 07/18/2017
Event Type  malfunction  
Event Description
Pension anesthesia machine prima 460, av-s display would not power. The unit would not power. Have to contact service for them to remove fuse on vent module and resets it. Then display powers on.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePENLON
Type of DevicePENLON
Manufacturer (Section D)
PENLON, INC.
minnetonka MN 55343
MDR Report Key6731289
MDR Text Key80786590
Report NumberMW5071119
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRIMA 460
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-