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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL PNEUPAC VENTILATOR, EMERGENCY

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SMITHS MEDICAL PNEUPAC VENTILATOR, EMERGENCY Back to Search Results
Device Problem Device Alarm System (1012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2018
Event Type  Injury  
Event Description
Pneupac vl1 "portable ventilator" lacks any alert/alarm to notify staff when oxygen flow ends. As this unit does not provide any type of room air bleed - in, once the oxygen source is depleted, no further breaths are delivered and no alarm to staff.
 
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Brand NamePNEUPAC
Type of DeviceVENTILATOR, EMERGENCY
Manufacturer (Section D)
SMITHS MEDICAL
minneapolis MN
MDR Report Key7323097
MDR Text Key101973969
Report NumberMW5075740
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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: 03/07/2018 Patient Sequence Number: 1
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