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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PNEUPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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PNEUPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Model Number 120003
Device Problems Device Alarm System (1012); Circuit Failure (1089); Premature Indicator Activation (3011)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/01/2020
Event Type  malfunction  
Event Description
It was reported that a smiths medical parapac ventilator had a faulty board, the device gave alarms.No adverse patient effects were reported.
 
Manufacturer Narrative
One pneupac ventilators parapac was returned for analysis.Upon visual inspection, the unit was observed to be undamaged.Functional testing was then performed revealing that the low battery light was flashing, 3.68 vdc was noted to be coming out of the battery holder assembly; confirming the complaint.Based on the evidence, the root cause was found to be unknown.
 
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Brand Name
PNEUPAC
Type of Device
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
MDR Report Key10204234
MDR Text Key196735840
Report Number3012307300-2020-06289
Device Sequence Number1
Product Code BTL
UDI-Device Identifier10610586045486
UDI-Public10610586045486
Combination Product (y/n)N
PMA/PMN Number
K020899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number120003
Device Catalogue Number120003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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