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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENTON LTD. PENTON ANESTHESIA DELIVERY UNIT GAS-MACHINE, ANESTHESIA

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PENTON LTD. PENTON ANESTHESIA DELIVERY UNIT GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number PRIMA 460
Device Problems Leak/Splash (1354); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2021
Event Type  malfunction  
Event Description
Upon intubation in main operating room, the anesthesia gas machine had a malfunction. The bellows would not rise all the way, suggesting a leak. The machine was changed and there was no adverse patient outcome. Fda safety report id# (b)(4).
 
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Brand NamePENTON ANESTHESIA DELIVERY UNIT
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
PENTON LTD.
MDR Report Key13236873
MDR Text Key283766961
Report NumberMW5106591
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 01/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2022
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? No Answer provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/11/2022 Patient Sequence Number: 1
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