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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENLON, INC. PENLON

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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.
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Brand NamePENLON
Type of DevicePENLON
Manufacturer (Section D)
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