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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENLON INC. PRIMA 460 ANESTHESIA DELIVERY UNIT / GAS - MACHINE, ANESTHESIA

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PENLON INC. PRIMA 460 ANESTHESIA DELIVERY UNIT / GAS - MACHINE, ANESTHESIA Back to Search Results
Model Number PRIMA 460
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/28/2019
Event Type  Injury  
Event Description
Prima 460 anesthesia machine became inoperable during surgery. Pt was manually bagged and new machine brought in to operating room. No pt harm. Fda safety report id# (b)(4).
 
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Brand NamePRIMA 460
Type of DeviceANESTHESIA DELIVERY UNIT / GAS - MACHINE, ANESTHESIA
Manufacturer (Section D)
PENLON INC.
MDR Report Key8671121
MDR Text Key147234614
Report NumberMW5087113
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 Risk Manager
Type of Report Initial
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2019
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? No Answer Provided
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/04/2019 Patient Sequence Number: 1
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