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MAUDE Adverse Event Report: PENLON, INC. PENLON
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PENLON, INC. PENLON
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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 Key
6731289
MDR Text Key
80786590
Report Number
MW5071119
Device Sequence Number
1
Product Code
BSZ
Combination Product (y/n)
N
Reporter Country Code
US
Number of Events Reported
1
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 Number
PRIMA 460
Was Device Available for Evaluation?
Yes
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
07/19/2017
Was Device Evaluated by Manufacturer?
No Information
Type of Device Usage
N
Patient Sequence Number
1
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