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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 Name
PENLON
Type of Device
PENLON
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
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPRIMA 460
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/19/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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