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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PENLON ANESTHESIA DELIVERY UNIT GAS-MACHINE, ANESTHESIA

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PHILIPS NORTH AMERICA LLC PENLON ANESTHESIA DELIVERY UNIT GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number PRIMA460
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/27/2020
Event Type  malfunction  
Event Description
Anesthesia machine was not reading tidal volume on pressure support when the patient was breathing spontaneously. Machine was replaced. No adverse patient outcome. Fda safety report id# (b)(4).
 
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Brand NamePENLON ANESTHESIA DELIVERY UNIT
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
MDR Report Key10051327
MDR Text Key190908680
Report NumberMW5094460
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 05/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRIMA460
Was Device Available for Evaluation? Yes
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: 05/12/2020 Patient Sequence Number: 1
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